Medical device recalls
Recalls
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Integra LifeSciences Corp. (NeuroSciences) medical device recall: CODMAN Disposable Perforator 11mm. Cranial Perforator
Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance of caution.
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IMPRIS Imaging Inc medical device recall: IMRIS Operating Suite
There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. Siemens notified IMRIS…
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Balt USA, LLC medical device recall: Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega…
Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen.
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Dexcom, Inc. medical device recall: Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product…
A software defect in version v1.15.0 of the G6 Android app can cause the app to terminate unexpectedly, which may result in the user not receiving estimated glucose…
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ICU Medical, Inc. medical device recall: IV Administration sets. 23
IV Gravity burette administration set burette component is missing an internal shutoff valve intended to stop fluid flow, which if used may result in delay in therapy…
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B Braun Medical Inc medical device recall: Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE…
The potential for micro-air bubbles observed in the bloodline and air-in-line alarms due to damaged arterial and venous patient connectors.
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Abiomed, Inc. medical device recall: Automated Impella Controller
Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures.
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Cook Medical Incorporated medical device recall: Zenith Alpha 2 Thoracic Endovascular Graft
Affected devices may contain PTFE coating scrapings. Scrapings could be released during device deployment, potentially causing intravascular embolization.
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Abbott medical device recall: TactiFlex Sensor Enabled Ablation Catheter
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
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Boston Scientific Corporation medical device recall: Accolade Sr Sl
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for…
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Olympus Corporation of the Americas medical device recall: Bronchovideoscope Olympus Bf Type 1T150
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and…
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Percussionaire Corporation medical device recall: Phasitron 5
IFU update; in-line valve, with pressure relief seal may leak when used with ventilator; don't use in neonates/infants, with target tidal volumes less-than50mL or…
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Abiomed, Inc. medical device recall: Automated Impella Controller
Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller (AIC).
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CareFusion 303, Inc. medical device recall: BD Alaris Pump Infusion Sets for the following reference numbers:…
Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and…
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Noxbox Ltd medical device recall: NOxBOXi Nitric Oxide Delivery System
Fluctuations may be more likely to occur if the total flow through the device sensor (used by the device to determine flow) is less than the minimum device requirement…
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Noxbox Ltd medical device recall: NOxBOXi Nitric Oxide Delivery System
The unexpected internal fault / system diagnostic error to result when a rapid succession of button selections is made to the user interface without waiting for the…
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Medline Industries, LP medical device recall: Medline Kits: 1) VALVE PACK-LF
The kits contain certain lots of cannula products where the catheter may not retain its shape.
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Siemens Medical Solutions USA, Inc medical device recall: Biograph mMR. Model Number: 10433372
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape…
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Draeger, Inc. medical device recall: Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number:…
The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
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Medline Industries, LP medical device recall: Reprocessed Livewire Steerable Electrophysiology Catheter Item…
Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on…
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Medline Industries, LP medical device recall: Sterile Medline Convenience Kits: 1) MAJOR PACK L-F
Convenience kits labeled as sterile have not gone through the sterilization process.
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Abiomed, Inc. medical device recall: Automated Impella Controller
Specific Automated Impella Controllers (AICs) that have a Pump Driver Circuit Assembly do not meet current specifications. This may lead to decreased pump performance or…
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MEDLINE INDUSTRIES, LP - Northfield medical device recall: Medline medical convenience kits labeled as: 1. ADULT INTUBATION TRAY
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles due to the…
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Max Mobility LLC medical device recall: Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC…
Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, their is a potential for lost of control of the device potentially…
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3M Company medical device recall: 3M Ranger Blood/Fluid Warming High Flow Set Catalog Numbers 24355
Field action to clarify the flow rates and inlet fluid temperatures, along with location of the outlet temperature for Ranger Blood/Fluid Warming High Flow Sets.
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Olympus Corporation of the Americas medical device recall: ViziShot 2FLEX. Single Use Aspiration Needle. Model Number:…
Potential for undetected, deformed a-traumatic tips.
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Boston Scientific Corporation medical device recall: WATCHMAN TruSeal Access System SGL
Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to…
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mo-Vis BVBA medical device recall: Micro Joystick R-net. Electrical wheelchair component
Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary neutral check and the…
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Baxter Healthcare Corporation medical device recall: Novum IQ LVP
Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software…
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Medtronic Perfusion Systems medical device recall: DLP Left Heart Vent Catheter Malleable body and vented connector
The catheters may not retain their shape.
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Dexcom, Inc. medical device recall: Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product…
The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier) and…
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MEDLINE INDUSTRIES, LP - Northfield medical device recall: Medline ReNewal Reprocessed St. Jude Medical Response and Supreme…
Specific lots of reprocessed electrophysiology catheters may contain small residual particulates.
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Tandem Diabetes Care, Inc. medical device recall: Battery Operated infusion pumps. t:slim X2 G5
Insulin pumps manufactured with speakers from Revision A and B may malfunction ("Malfunction 16") which prevents audible alerts and causes the pumps to become inoperable…
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Boston Scientific Corporation medical device recall: Endotak Reliance G/Sg
Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early…
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Hamilton Medical AG medical device recall: Hamilton C6 REF 160021
A mechanical defect on a printed circuit board (PCB) as a result of PCB separating process. This defect might cause the ventilator to either fail at startup (no patient…
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Thoratec LLC medical device recall: Brand Name: HeartMate Product Name: Mobile Power Unit
Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking mechanism from properly engaging with the Mobile Power Unit and may…
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Boston Scientific Corporation medical device recall: Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding…
Certain batches are being removed due to an increase in complaints received in which physicians encountered greater than anticipated resistance while attempting to…
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Philips Respironics, Inc. medical device recall: DreamStation Auto CPAP. Non-Continuous Ventilator
Devices may possess a programming error resulting in an incorrect device configuration.
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Ambu Inc. medical device recall: Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator
Potential for the manometer port being blocked rendering the manometer non-functional.
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Baxter Healthcare Corporation medical device recall: Baxter Novum IQ Large Volume Pump
Baxter is issuing an Urgent Medical Device Correction for the Novum IQ large volume pump (LVP) due to the potential for underinfusion when transitioning from a flow rate…
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ICU Medical, Inc. medical device recall: Plum Duo Infusion System
ICU Medical identified two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive.
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B Braun Medical Inc medical device recall: Microbore Extension Set with 0.2 Micron Filter. Catalog Number:…
Label is incorrect. The product label indicates that the device contains an air eliminating filter. However, the filter utilized on this extension set is not indicated…
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Flexicare Medical (Dongguan) Ltd. medical device recall: BritePro Solo Single-Use Fiber Optic Mini Handle and Blade Ref:…
Laryngoscope handles may not illuminate as intended.
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CareFusion 303, Inc. medical device recall: BD Alaris Pump Module Model
Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and…
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Hamilton Medical AG medical device recall: Breathing circuit set
Ventilator coaxial breathing circuit may have a crack in blue tubing, which is used to deliver fresh gas to the patient. The crack will compromise inspiratory and…
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Abiomed, Inc. medical device recall: Automated Impella Controller
A potential issue with the Automated Impella Controller (AIC) not detecting an Impella pump when it is connected
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Draeger, Inc. medical device recall: SafeStar 90 Plus Filter. Bidirectionally breathing system filter
Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
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Intersurgical Inc medical device recall: i-view video laryngoscope. Model Number: 8008000. The i-view video…
Potential for faulty devices as a result of depleted batteries.
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Baxter Healthcare Corporation medical device recall: Baxter SIGMA Spectrum Infusion Pump V6
Certain Spectrum infusion pumps may have an incorrect version of software.
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Given Imaging Ltd. medical device recall: Bravo CF capsule delivery device
It has been determined that misapplied adhesive on the Bravo CF capsule delivery device may lead to its malfunction. Specifically, the misapplied adhesive may prevent…