Bard Peripheral Vascular Inc recalls
57 recalls in our records from 2013 to 2026: 57 FDA medical devices.
Recalls with full detail pages
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Bard Peripheral Vascular Inc medical device recall: Rotarex Atherectomy System and Instructions for Use
Atherectomy Catheter eIFU updated to clarify and emphasize procedural steps intended to reduce the likelihood of catheter breakage events. Catheter has an outer cylinder…
Earlier and other recalls
These link to the official agency notice.
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Bard Peripheral Vascular Inc medical device recall: EnCor EnCompass Breast Biopsy and Tissue Removal System Console Official notice ↗
Breast biopsy and tissue removal system may experience the following errors: 1) Probe calibration and /or handheld driver failure (code HH01-00020009) , 2) Pressure…
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Bard Peripheral Vascular Inc medical device recall: Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff… Official notice ↗
Due to damage to outer tray that can potentially compromise the sterile barrier
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Bard Peripheral Vascular Inc medical device recall: Safe-T-Centesis 6 Fr Catheter Drainage Tray Official notice ↗
Acute drainage catheters, indicated for use in removing fluid during acute drainage/aspiration procedure, manufactured with safety indicators that erroneously show…
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Bard Peripheral Vascular Inc medical device recall: Venclose digiRF Generators Official notice ↗
Software version 3.35 of the Venclose digiRF Generator incorporates a catheter verification feature specifically designed to detect internal wiring anomalies in Venclose…
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Bard Peripheral Vascular Inc medical device recall: Bard Marquee Disposable Core Biopsy Instrument Kit: BARD MARQUEE KIT… Official notice ↗
Disposable biopsy instruments were potentially manufactured missing the backend notch retention feature on the needle that results in inadequate securing of the needle…
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Bard Peripheral Vascular Inc medical device recall: The EVSRF catheter is a sterile Official notice ↗
The Venclose" RF Ablation Catheters may have been manufactured with internal wiring error. The red and yellow signal wires were soldered on swapped ports of the catheter…
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Bard Peripheral Vascular Inc medical device recall: BARD MAGNUM Disposable Core Tissue Biopsy Needle REF: MN1410 MN 1420… Official notice ↗
Due to possible packaging damage (indentations/cuts) cause by manufacturing process. As a result of the packaging damage, may cause the sterile barrier to be compromised.
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Bard Peripheral Vascular Inc medical device recall: Guidewire 70cm x 1mm Official notice ↗
Due to guidewires being manufactured incorrectly with the guidewires being mis-assembled within the hoop such that the proximal (stiff) end of the guidewire is located…
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Bard Peripheral Vascular Inc medical device recall: BD Recanalization System Official notice ↗
Recanalization systems may be in a manufacturing mode that allows the system to continuously run without the typical 30 second pauses, and 4-minute warning/5-minute…
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Bard Peripheral Vascular Inc medical device recall: Bard Mission Disposable Core Biopsy Instrument Kit Official notice ↗
The internal diameter of the coaxial cannula may be smaller or larger than the external diameter of the biopsy needle, and the length of the cannula may exceed the…
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Bard Peripheral Vascular Inc medical device recall: Bard Marquee Disposable Core Biopsy Instrument Kit Official notice ↗
Diameter mismatch between coaxial and biopsy needle (cutting cannula) in disposable core biopsy instrument kits, where the coaxial cannula inner diameter prohibits the…
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Bard Peripheral Vascular Inc medical device recall: Bard Mission Disposable Core Biopsy Instrument Kit: REF: 2010MSK Official notice ↗
Coaxial cannula internal diameter and length of biopsy instruments exceed the external diameter and length of the biopsy needle, prohibiting the biopsy needle from…
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Bard Peripheral Vascular Inc medical device recall: Bard Mission Disposable Core Biopsy Instrument Kit: 16G x 10CM Official notice ↗
The external diameter of the biopsy instrument is larger than the internal diameter of the coaxial needle, which could lead to: 1) Procedural delay, 2) Requirement of an…
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Bard Peripheral Vascular Inc medical device recall: The Covera Vascular Covered Stent is a flexible Official notice ↗
An increase in the reported complaint rate for inability to deploy was identified and related to poor slide block bonding.
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Bard Peripheral Vascular Inc medical device recall: Catalog Number / Product Description 0601600 2.7F Broviac CV Catheter… Official notice ↗
Due to the adhesive provided within the catheter repair kits maybe hardened/coagulated (unusable).
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Bard Peripheral Vascular Inc medical device recall: Ref: Pig1260K Official notice ↗
There is the potential that a 6 Fr Catheter Drainage kit contains an 8 Fr needle instead of a 6 Fr needle. They can be used in conjunction with the following drainage…
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Bard Peripheral Vascular Inc medical device recall: Safe-T PLUS Pediatric/Infant Lumbar Puncture Tray Official notice ↗
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
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Bard Peripheral Vascular Inc medical device recall: Catalog # BEK4511 Official notice ↗
Due to misbranded products shipped to customers.
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Bard Peripheral Vascular Inc medical device recall: Ref Tin3015 Official notice ↗
Potential for needle protector to become fully dislodge exposing infusion needle which could result in needle stick.
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Bard Peripheral Vascular Inc medical device recall: TJM6008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with… Official notice ↗
Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile.
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Bard Peripheral Vascular Inc medical device recall: VENOVO Venous Stent System 10F Product Description(REF)/dimension:… Official notice ↗
Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.
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Bard Peripheral Vascular Inc medical device recall: PowerPort duo M.R.I. Implantable Port Official notice ↗
Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements.
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Bard Peripheral Vascular Inc medical device recall: BARD MARQUEE Disposable Core Biopsy Instruments XX.Xcm Official notice ↗
Due to the Penetration Depth Switch used to select the desired penetration depth of the biopsy needle for soft tissue biopsies, detaches from the device during use.
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Bard Peripheral Vascular Inc medical device recall: Bard Conquest PTA Balloon dilation Catheter Official notice ↗
Dilation catheter packaged with the wrong size balloon. The labeling states that the balloon size is 6mm x 40mm, however included is a 5mm x 40mm balloon. Use of a…
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Bard Peripheral Vascular Inc medical device recall: EQUISTREAM¿ XK Long-Term Hemodialysis Catheter.… Official notice ↗
Incorrect Peel-Apart Introducer Sheath in Kit.
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Bard Peripheral Vascular Inc medical device recall: BARD Access Systems PowerPort ClearVUE Slim Implantable Port With… Official notice ↗
The catheter locks for the lot may contain an 8Fr catheter lock instead of a 6Fr catheter lock per device labeling.
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Bard Peripheral Vascular Inc medical device recall: Jamshidi Bone Marrow Biopsy/Aspiration Needle Official notice ↗
Sterility compromised due to packaging pouches that may not be sealed properly
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Bard Peripheral Vascular Inc medical device recall: BD WAVELINQ 4F EndoAVF System Official notice ↗
The firm has become aware of a potential problem with their venous and arterial magnetic catheters may be at risk of experiencing a magnetic deficiency, which may result…
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Bard Peripheral Vascular Inc medical device recall: 1.PowerPort Implantable Port With Attachable 9.6 F Open-Ended… Official notice ↗
Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb…
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Bard Peripheral Vascular Inc medical device recall: Bard Biopsy EnCor Probe Official notice ↗
Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was conducted due to an increase in probe failures for leaks,…
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Bard Peripheral Vascular Inc medical device recall: Bard Conquest 40 PTA Dilation Catheter Official notice ↗
The catheter packaging incorrectly listed the balloon size as 8mm X 20mm instead of the intended size 8mm X 40mm. If undetected, the user will advance the longer than…
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Bard Peripheral Vascular Inc medical device recall: BARD MAX-CORE Disposable Core Biopsy Instrument - Product Usage: The… Official notice ↗
During the firm's review of May 2019 complaint data, a significant increase in Disposable Core Biopsy Instrument complaints were observed for Failure to Fire, Firing…
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Bard Peripheral Vascular Inc medical device recall: LIFESTREAM Balloon Expandable Vascular Covered Stent . BARD… Official notice ↗
Certain product code/lot number combinations may experience introducer sheath compatibility issues when used with a 6F introducer sheath. Using the affected balloon…
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Bard Peripheral Vascular Inc medical device recall: PowerPort isp M.R.I. Implantable Port with Attachable 8F Polyurethane… Official notice ↗
Complaints received that products packaged with the incorrect introducer sheath size.
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Bard Peripheral Vascular Inc medical device recall: Equistream Long-Term Hemodialysis Catheter Official notice ↗
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
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Bard Peripheral Vascular Inc medical device recall: EnCor Breast Biopsy Probes Official notice ↗
There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product.
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Bard Peripheral Vascular Inc medical device recall: POWERPORT CLEARVUE isp Official notice ↗
Certain NAUTILUS DELTA Port Kit product code / lot number combinations may be at risk of experiencing a lack of or a loss of the intravascular ECG signal during port…
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Bard Peripheral Vascular Inc medical device recall: BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter Official notice ↗
Device is at risk of having detectable levels of bacterial endotoxin present on the packaging hoop that the catheter is packaged in. The bacterial endotoxin levels for…
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Bard Peripheral Vascular Inc medical device recall: POWERPORT(R) ClearVUE(R) isp with Smooth Septum Official notice ↗
The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
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Bard Peripheral Vascular Inc medical device recall: BARD MAX-CORE Disposable Core Biopsy Instrument Official notice ↗
During the review of May 2017 complaint data, a significant increase in MAX-CORE Disposable Core Biopsy Instrument complaints was observed for Failure to Prime, Failure…
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Bard Peripheral Vascular Inc medical device recall: MR GHIATAS Beaded Breast Localization Wire Official notice ↗
It may be at risk of containing a non-MR compatible GHIATAS Beaded Breast Localization Wire instead of a MR compatible GHIATAS Beaded Breast Localization Wire.
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Bard Peripheral Vascular, Inc medical device recall: Halo One 5F Introducer Sheath 45 cm Product Code: HAL545 The Halo One… Official notice ↗
Complaints of sheath separation, kinking, and/or tip damage during use.
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Bard Peripheral Vascular Inc medical device recall: Bard TruGuide Disposable Coaxial Biopsy Needle Mixed Product Part… Official notice ↗
May contain two trocar tip stylets with coaxials or two blunt tip stylets instead of one of each.
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Bard Peripheral Vascular Inc medical device recall: Bard TruGuide Disposable Coaxial Biopsy Needle Product Usage: The… Official notice ↗
Bard Peripheral Vascular, Inc. is recalling Bard TruGuide Disposable Coaxial Biopsy Needles because they have the potential to have the incorrect sized blunt tip stylet…
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Bard Peripheral Vascular Inc medical device recall: Denali Filter-Jugular/Subclavian Delivery System Product Code:… Official notice ↗
Bard Peripheral Vascular, Inc. is recalling Denali Filter-Jugular/Subclavian Delivery System and Denali Filter-Femoral Delivery System because of the stop cocks…
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Bard Peripheral Vascular Inc medical device recall: Bard Distaflo Vascular Bypass Graft Official notice ↗
Size mislabeling; the graft is labeled as a 6 mm diameter graft when the actual packaged product is an 8 mm graft.
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Bard Peripheral Vascular Inc medical device recall: Denali Filter-Jugular/Subclavian DL950J Denali Filter-Femoral… Official notice ↗
IFU missing contraindications: Patients with uncontrolled sepsis and Patients with known hypersensitivity to nickel-titanium alloys.
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Bard Peripheral Vascular Inc medical device recall: FLAIR Endovascular Stent Graft Official notice ↗
Bard Peripheral Vascular (BPV) is recalling the Bard Flair Endovascular Stent Graft because of the harm associated with failure to deploy or deployment related issues…
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Bard Peripheral Vascular Inc medical device recall: BARD MAX-CORE Disposable Core Biopsy Instrument Gauge x Length 18g x… Official notice ↗
The firm is recalling Bard MAX-CORE Disposable Core Biopsy Instrument due to the risk of having self-activation-related issues.
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Bard Peripheral Vascular Inc medical device recall: Bard ConQuest PTA Balloon Dilatation Catheter Official notice ↗
Bard Peripheral Vascular is recalling the Bard ConQuest PTA Balloon Dilatation Catheter because it may be at risk of having deflation related issues.
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Bard Peripheral Vascular Inc medical device recall: Bard Monopty Disposable Core Biopsy Instruments and Kits Official notice ↗
Bard Peripheral Vascular is recalling the Bard Monopty Disposable Core Biopsy Instruments and Kits because they may be at risk of having activation-related issues.
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Bard Peripheral Vascular Inc medical device recall: Bard DuaLok Breast Lesion Localization Wire Official notice ↗
Bard Peripheral is recalling the Bard DuaLok Breast Lesion Localization Wire because it may be at risk of having portions of the wire protruding from the packaging, thus…
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Bard Peripheral Vascular Inc medical device recall: Bard LifeStent Solo Vascular Stent Official notice ↗
Bard Peripheral Vascular is recalling specific lots of Bard Lifestent Solo Vascular Stent because they have determined a higher incidence rate of partial stent…
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Bard Peripheral Vascular Inc medical device recall: BARD PERIPHERAL VASCULAR VACCESS¿ PTA Balloon Dilatation Catheters Official notice ↗
Bard Peripheral Vascular (BPV) has confirmed that some product code/lot number combination of devices may have the incorrect balloon diameter labeled on the inflation…
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Bard Peripheral Vascular Inc medical device recall: BARD Biopsy Systems UltraClip Dual Trigger breast tissue marker.… Official notice ↗
Bard Peripheral Vascular (BPV) has confirmed that some devices with the recalled product code / lot number combination may have the metal tissue marker separated from…
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Bard Peripheral Vascular Inc medical device recall: BARD Biopsy Systems Official notice ↗
Bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard¿ UltraClip¿ Dual Trigger Tissue Marker's and support catheters (Microsheath and…
Firm names are matched across agencies by name only. Different companies with similar names may be grouped together; check each official notice.