Edwards Lifesciences, LLC recalls
50 recalls in our records from 2012 to 2026: 50 FDA medical devices.
Recalls with full detail pages
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Edwards Lifesciences, LLC medical device recall: Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial…
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
Earlier and other recalls
These link to the official agency notice.
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Edwards Lifesciences, LLC medical device recall: Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO Official notice ↗
Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.
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Edwards Lifesciences, LLC medical device recall: Acumen IQ Sensor Official notice ↗
Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
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Edwards Lifesciences, LLC medical device recall: Fogarty Thru-Lumen Embolectomy Catheter Official notice ↗
Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds).
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Edwards Lifesciences, LLC medical device recall: PASCAL Precision Transcatheter Valve Repair System Official notice ↗
Due to a manufacturing issue, when using valve repair systems, intended to repair insufficient mitral and/or tricuspid valves, users experienced resistance when…
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Edwards Lifesciences, LLC medical device recall: Edward Lifesciences Official notice ↗
There is a potential that the distal end of the catheter may be bent beyond its intended curvature and when connected to patient monitoring device, the monitor may…
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Edwards Lifesciences, LLC medical device recall: Fogarty Arterial Embolectomy Catheters Model Number: 120602FP… Official notice ↗
Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches.
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Edwards Lifesciences, LLC medical device recall: FORE-SIGHT ELITE Absolute Tissue Oximeter Official notice ↗
The StO2 values may be inaccurately low when using either the FORE-SIGHT ELITE Tissue Oximeter Module or the FORE-SIGHT ELITE Absolute Tissue Oximeter Monitor with the…
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Edwards Lifesciences, LLC medical device recall: Edwards PediaSat Oximetry Catheter Kit Official notice ↗
There is a potential for internal leaks within catheters.
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Edwards Lifesciences, LLC medical device recall: Edwards TruWave Official notice ↗
There is a potential that the pressure tubing may detach from the blood sampling system
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Edwards Lifesciences, LLC medical device recall: Sterile Oxymetry Oligon Catheter Kit. Pressure injectable.… Official notice ↗
Sterile catheter kit packaging compromised.
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Edwards Lifesciences, LLC medical device recall: Oxymetry Cable Official notice ↗
Intermittent communication due to inconsistent crimping of connectors onto cables.
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Edwards Lifesciences, LLC medical device recall: QuickDraw Venous Cannula Official notice ↗
If the venous cannula is used in an unintended manner (longer than 6 hours; particularly during extracorporeal membrane oxygenation [ECMO]) there is a risk that…
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Edwards Lifesciences, LLC medical device recall: EZ Glide Aortic Cannula Official notice ↗
Their is a possibility that the cannula may separate from its connector, potentially causing a breach of circuit during cardiopulmonary bypass which could result in…
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Edwards Lifesciences, LLC medical device recall: Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System Official notice ↗
The action has been initiated to address reports of burst balloons which have resulted in significant difficulty retrieving the device into the sheath and withdrawing…
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Edwards Lifesciences, LLC medical device recall: IntraClude Intra-Aortic Occlusion Device Official notice ↗
Possibility of balloon rupture in intra-aortic occlusion devices. If the balloon bursts during cardiopulmonary bypass, the heart can fill and warm, the operative site…
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Edwards Lifesciences, LLC medical device recall: EV1000 Clinical Platform Official notice ↗
Potential for an electrical short circuit leading to possible fire hazard due to liquid ingress into AC power outlets.
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Edwards Lifesciences, LLC medical device recall: Edwards Lifesciences Official notice ↗
Difficulty with atrioseptostomy catheter balloon deflation after deployment, and reports of balloon fragmentation or detachment.
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Edwards Lifesciences, LLC medical device recall: Edwards Lifesciences(R) IntraClude(TM) Intra-Aortic Occlusion Device… Official notice ↗
Edwards Lifesciences has received a limited number of customer reports regarding an inter-lumen leak between the cardioplegia lumen and pressure lumen in the device.
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Edwards Lifesciences, LLC medical device recall: Edward Lifesciences Official notice ↗
This action has been initiated to address complaint reports received for crimp balloon and inflation balloon component separation during TAVR procedures.
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Edwards Lifesciences, LLC medical device recall: Edwards Lifesciences Swan Ganz Thermodilution Catheter Official notice ↗
These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If the lumens are reversed the clinician may note reverse PA and CVP…
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Edwards Lifesciences, LLC medical device recall: Edwards SAPIEN 3 Transcatheter Heart Valve Official notice ↗
SAPIEN 3 THV was packaged with the incorrect valve size with respect to the label.
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Edwards Lifesciences, LLC medical device recall: Edwards Lifesciences' IntraClude Intra-Aortic Occlusion Device.… Official notice ↗
Possible leak at distal open end of the strain relief, which causes medical staff to continue adding inflation fluid to maintain balloon pressure for adequate occlusion…
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Edwards Lifesciences, LLC medical device recall: Hemosphere System with the following three components: HEM1 Advanced… Official notice ↗
Pre-procedural issues related to software defects
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Edwards Lifesciences, LLC medical device recall: Certitude Delivery System and any associated Multipacks Models -… Official notice ↗
A component in the Certitude Loader may have a molding overflow defect that could detach during advancement of the delivery system and potentially embolize from the…
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Edwards Lifesciences, LLC medical device recall: Fogarty Adherent Clot Catheter Model Numbers 1408010 and 140806… Official notice ↗
The diameter of the Fogarty Catheter balloon, measures 6mm instead of 10mm.
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Edwards Lifesciences, LLC medical device recall: Intravascular Official notice ↗
Edward Lifesciences is recalling Intravascular (IV) Administration Sets due to the requirement of an additional FDA submission to support commercialization (clearance)…
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Edwards Lifesciences, LLC medical device recall: Thin-Flex Venous Cannula Official notice ↗
Edwards Lifesciences initiated a field action for the Thin-Flex Venous Cannula (Model TF292902A) because the connector size is incorrectly described in the Edwards…
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Edwards Lifesciences, LLC medical device recall: ThruPort Knot Pusher. This device is sold individually Official notice ↗
The configuration of the slot at the tip of the knot pusher may inhibit intended ease of use. Fraying or splitting of the suture could occur, which could compromise the…
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Edwards Lifesciences, LLC medical device recall: Edwards Lifesciences IntraClude Intra-Aortic Occlusion Device Official notice ↗
Potential device damage on the strain relief near the hub area, which may result in blood leakage.
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Edwards Lifesciences, LLC medical device recall: ClearSight Official notice ↗
Edward Lifesciences is recalling the ClearSight System because the finger component of the Heart Reference Sensor may be damaged.
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Edwards Lifesciences, LLC medical device recall: Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number… Official notice ↗
The product failed to meet the internal established statistical test requirement for heparin activity.
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Edwards Lifesciences, LLC medical device recall: Edwards Lifesciences Fem-Flex II Femoral Arterial Cannula 8 Official notice ↗
Edwards Lifesciences is recalling Fem-Flex II Pediatric Femoral Arterial Cannula sizes 8, 10, 12 French because of the potential of tissue damage caused by a protruding…
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Edwards Lifesciences, LLC medical device recall: Edwards Lifesciences Vent Catheters Official notice ↗
Edwards Lifesciences is conducting a field action on the Vent Catheters due to the potential for disruption of the white plastic coating on the stylet.
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Edwards Lifesciences, LLC medical device recall: Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae Official notice ↗
Potential for separation of dilator tips.
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Edwards Lifesciences, LLC medical device recall: Crimper Model 9100CR26 The Crimper is indicated for use in preparing… Official notice ↗
Edwards Lifesciences is recalling two lot numbers of the 26mm transcatheter heart valve crimper because they may not open sufficiently when the handle is rotated in the…
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Edwards Lifesciences, LLC medical device recall: Edwards Lifesciences Ergonic Double Acting DeBakey Forceps with… Official notice ↗
Edwards Lifesciences is recalling one lot of Ergonic instrument due to mislabeling. Ergonic scissors standard curved labeled as a Double Acting DeBakey forcep. Edwards…
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Edwards Lifesciences, LLC medical device recall: Edwards Lifesciences Fem-Flex Femoral Arterial Cannula with Duraflo… Official notice ↗
Edwards Lifesciences is recalling two lots of Duraflo Cannulas due to reported complaints involving cracks in the t-connector of the devices which were confirmed during…
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Edwards Lifesciences, LLC medical device recall: Edwards Lifesciences EMBOL-X Glide Protection System Official notice ↗
Edwards Lifesciences is recalling certain lots of EMBOL-X Glide Protection System due to deformation of the cannula tip.
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Edwards Lifesciences, LLC medical device recall: ***Flo Trac Sensor Model MHD85***" Sterile Official notice ↗
The Edwards Lifesciences FloTrac Sensor is being recalled due to a manufacturing non-conformance related to incorrect packaging configuration where the IFU was placed on…
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Edwards Lifesciences, LLC medical device recall: Edwards Lifesciences Anastaflo Intravascular Shunt Official notice ↗
Edwards Lifesciences is recalling certain lots of the Anastaflo intravascular Shunt due to concerns of excessive adhesive on the shunt body that may interfere with…
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Edwards Lifesciences, LLC medical device recall: Edwards EndoReturn Arterial Cannula Official notice ↗
Edwards Lifesciences is recalling certain lots of the EndoReturn Arterial Cannula that were built with an incorrect component. This component can create a performance…
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Edwards Lifesciences, LLC medical device recall: Edwards Lifesciences Suction Wand Official notice ↗
Edwards is recalling certain lots of Rigid Suction Wands because they discovered plastic particulate inside the sterile pouch and within the internal diam ether of the…
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Edwards Lifesciences, LLC medical device recall: QuickDraw Venous Cannula with Insertion Kit. ThruPort Systmes. Models… Official notice ↗
Edwards is recalling the QuickDraw Venous Cannula due to complaints of cannula separation during withdrawal of the device when the Percutaneous insertion method is used.
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Edwards Lifesciences, LLC medical device recall: Proplege Coronary Sinus Catheter model PR9 Official notice ↗
Edwards Lifesciences is recalling certain Proplege Coronary Sinus Catheter, model PR9 due to confirmed reports of blood leakage through the hemostasis valve in the…
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Edwards Lifesciences, LLC medical device recall: Edwards Lifesciences Duraflo coated Femoral Cannula. Product Usage:… Official notice ↗
Two unsealed pouches were found at an Edwards' distribution location in Japan. Incorrectly sealed pouches may result in a sterility barrier breach.
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Edwards Lifesciences, LLC medical device recall: Edwards Lifesciences Crimpers Official notice ↗
Holes in the sterile barrier pouch may be caused by handling of the device during manufacturing or once pouches have been removed from the unit box and stored on the…
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Edwards Lifesciences, LLC medical device recall: Pressure Monitoring sets with VAMP Plus closed blood sampling system… Official notice ↗
The device is being recalled because the firm has received multiple complaints related to incorrect assembly that may result in dilution of blood samples.
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Edwards Lifesciences, LLC medical device recall: Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model… Official notice ↗
The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the…
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Edwards Lifesciences, LLC medical device recall: Edwards Lifesciences Rigid Suction Wand Official notice ↗
Edwards is recalling Suction Wand models SPC2081 and S033 because the plastic tip attached to the metal suction wand may become detached during routine use.
Firm names are matched across agencies by name only. Different companies with similar names may be grouped together; check each official notice.