Edwards Lifesciences recalls
Edwards Lifesciences appears in 95 official U.S. recall notices indexed by RecallRadar.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131VF7P Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnos…
FDA Device · Class I · 2019-02-06 · Edwards Lifesciences
Reason: 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 pressure values and waveforms. - Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF131F 7J Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnost…
FDA Device · Class I · 2019-02-06 · Edwards Lifesciences
Reason: 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 pressure values and waveforms. - Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131F7P (5 pack of 131F7) Product Usage: The Swan-Ganz Thermodilution Catheter p…
FDA Device · Class I · 2019-02-06 · Edwards Lifesciences
Reason: 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 pressure values and waveforms. - Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm
FDA Device · Class II · 2018-07-25 · Edwards Lifesciences
Reason: SAPIEN 3 THV was packaged with the incorrect valve size with respect to the label. - Edwards Lifesciences' IntraClude Intra-Aortic Occlusion Device
FDA Device · Class II · 2018-05-30 · Edwards Lifesciences
Reason: 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 of the ascending aorta. - Hemosphere System with the following three components: HEM1 Advanced Monitor, HEMSGM10 (Swan-Ganz Module), and HEMOXSC100 (Oximetry Smart C…
FDA Device · Class II · 2018-02-07 · Edwards Lifesciences
Reason: Pre-procedural issues related to software defects - Certitude Delivery System and any associated Multipacks Models - 9600CT20A, 9600CT23A, 9600CT26A, 9600CT29A Product Usage: The Edwards Cert…
FDA Device · Class I · 2018-01-17 · Edwards Lifesciences
Reason: 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 loader into the patient. - Fogarty Adherent Clot Catheter Model Numbers 1408010 and 140806 Product Usage: The Fogarty adherent clot catheters are designed to effectiv…
FDA Device · Class II · 2017-09-06 · Edwards Lifesciences
Reason: The diameter of the Fogarty Catheter balloon, measures 6mm instead of 10mm. - Intravascular (IV) Administration Sets, Model No. 54IV12, 54IV22, 54IV32, MK2450, 54IV42, MK132, MK2156, MK2270, MK2292, MK2300, MK2374, MK…
FDA Device · Class II · 2015-12-23 · Edwards Lifesciences
Reason: Edward Lifesciences is recalling Intravascular (IV) Administration Sets due to the requirement of an additional FDA submission to support commercialization (clearance) of the devices. - Thin-Flex Venous Cannula, Model Number:TF292902A
FDA Device · Class II · 2015-12-16 · Edwards Lifesciences
Reason: Edwards Lifesciences initiated a field action for the Thin-Flex Venous Cannula (Model TF292902A) because the connector size is incorrectly described in the Edwards product guide as 3/8 inch. The actual and correct conne… - ThruPort Knot Pusher
FDA Device · Class II · 2015-09-30 · Edwards Lifesciences
Reason: 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 integrity of the suture knot. - Edwards Lifesciences IntraClude Intra-Aortic Occlusion Device, model number ICF100, 10.5 Fr (3.5 mm) x 39.4" (100 cm) ThruPort System
FDA Device · Class II · 2015-06-17 · Edwards Lifesciences
Reason: Potential device damage on the strain relief near the hub area, which may result in blood leakage. - ClearSight, Model No. EVHRS Heart Reference Sensor
FDA Device · Class II · 2015-06-17 · Edwards Lifesciences
Reason: Edward Lifesciences is recalling the ClearSight System because the finger component of the Heart Reference Sensor may be damaged. - Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number 744HF75
FDA Device · Class II · 2015-06-10 · Edwards Lifesciences
Reason: The product failed to meet the internal established statistical test requirement for heparin activity. - Edwards Lifesciences Fem-Flex II Femoral Arterial Cannula 8, 10, 12 French,Sterile EO, Rx Only, Manufacturer Edwards Lifesciences LLC, Irvi…
FDA Device · Class II · 2015-04-08 · Edwards Lifesciences
Reason: 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 wire located at the tip of the cannula. - Edwards Lifesciences Vent Catheters, . Packaged sterile and non-pyrogenic in a sealed, peel-type pouch
FDA Device · Class II · 2014-11-26 · Edwards Lifesciences
Reason: 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. - Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae with Duraflo Coating, arterial cannula sizes 16, 18 and 20 French, Models DF…
FDA Device · Class II · 2014-04-23 · Edwards Lifesciences
Reason: Potential for separation of dilator tips. - Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae, arterial cannula sizes 16, 18 and 20 French, models: FEMII016A, FEMII016AS,…
FDA Device · Class II · 2014-04-23 · Edwards Lifesciences
Reason: Potential for separation of dilator tips. - Crimper Model 9100CR26 The Crimper is indicated for use in preparing the Edwards SAPIEN Transcatheter Heart Valve for implantation
FDA Device · Class II · 2014-02-12 · Edwards Lifesciences
Reason: 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 full open position. As a result, user may have dif… - Edwards Lifesciences Ergonic Double Acting DeBakey Forceps with Narrow Straight Tip
FDA Device · Class III · 2014-01-01 · Edwards Lifesciences
Reason: Edwards Lifesciences is recalling one lot of Ergonic instrument due to mislabeling. Ergonic scissors standard curved labeled as a Double Acting DeBakey forcep. Edwards control confirmed that the laser etching on the dev… - Edwards Lifesciences Fem-Flex Femoral Arterial Cannula with Duraflo Coating, DIITFA02225, Sterile, RX only For Single Use Only, Product Usa…
FDA Device · Class II · 2013-11-13 · Edwards Lifesciences
Reason: 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 product evaluation. - Edwards Lifesciences Dispersion Aortic Perfusion Cannula with Duraflo Coating, Sterile, RX only For Single Use Only, Product Usage: Aortic…
FDA Device · Class II · 2013-11-13 · Edwards Lifesciences
Reason: 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 product evaluation. - Edwards Lifesciences EMBOL-X Glide Protection System
FDA Device · Class I · 2013-11-06 · Edwards Lifesciences
Reason: Edwards Lifesciences is recalling certain lots of EMBOL-X Glide Protection System due to deformation of the cannula tip. - "***Flo Trac Sensor Model MHD85***" Sterile, single use kit that monitors pressures when attached to pressure monitoring catheters
FDA Device · Class II · 2013-09-18 · Edwards Lifesciences
Reason: 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 top of the Tyvek instead of being placed at the b… - Edwards Lifesciences Anastaflo Intravascular Shunt, Model code IVS12512, IVS1512, IVS17512, IVS2012, IVS2512, IVS3012, IVS1530, IVS2030 and…
FDA Device · Class II · 2013-08-21 · Edwards Lifesciences
Reason: 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 suturing of by-pass grafts. - Edwards EndoReturn Arterial Cannula, model ER21B and ER23B Product Usage: The ThruPort EndoReturn arterial cannula kit (with or without hem…
FDA Device · Class II · 2013-08-21 · Edwards Lifesciences
Reason: Edwards Lifesciences is recalling certain lots of the EndoReturn Arterial Cannula that were built with an incorrect component. This component can create a performance problem with the IntraClude IntraAortic Occlusion de… - Edwards Lifesciences Suction Wand, models S099 and S0998B Suction wands are intended for hand held use and pericardial sumps are intended f…
FDA Device · Class II · 2013-07-24 · Edwards Lifesciences
Reason: 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 wand. - QuickDraw Venous Cannula with Insertion Kit
FDA Device · Class II · 2013-06-19 · Edwards Lifesciences
Reason: 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. - Proplege Coronary Sinus Catheter model PR9, 11 French Introducer, kitted with PR9. Product Usage: The catheter introducer sheath kit provid…
FDA Device · Class II · 2013-05-22 · Edwards Lifesciences
Reason: Edwards Lifesciences is recalling certain Proplege Coronary Sinus Catheter, model PR9 due to confirmed reports of blood leakage through the hemostasis valve in the introducer that is kitted with the catheter. - Edwards Lifesciences Duraflo coated Femoral Cannula
FDA Device · Class II · 2013-04-24 · Edwards Lifesciences
Reason: Two unsealed pouches were found at an Edwards' distribution location in Japan. Incorrectly sealed pouches may result in a sterility barrier breach. - Edwards Lifesciences Crimpers, Model 9100CR26
FDA Device · Class II · 2013-04-24 · Edwards Lifesciences
Reason: 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 shelf by customers. - Pressure Monitoring sets with VAMP Plus closed blood sampling system model # T001691A, PXVP0566, PXVP2260, PXVP0826, PXVP0827, PXVP2284AT3,…
FDA Device · Class II · 2013-04-24 · Edwards Lifesciences
Reason: The device is being recalled because the firm has received multiple complaints related to incorrect assembly that may result in dilution of blood samples. - Edwards Lifesciences Crimpers, Model 9100CR23
FDA Device · Class II · 2013-04-24 · Edwards Lifesciences
Reason: 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 shelf by customers. - Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151F7. For use in patients who require hemodynamic monitoring
FDA Device · Class II · 2012-08-22 · Edwards Lifesciences
Reason: 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 catheter. - Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7P. For use in patients who require hemodynamic monitoring
FDA Device · Class II · 2012-08-22 · Edwards Lifesciences
Reason: 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 catheter. - Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HVF7P. For use in patients who require hemodynamic monitoring
FDA Device · Class II · 2012-08-22 · Edwards Lifesciences
Reason: 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 catheter. - Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7P. For use in patients who require hemodynamic monitoring
FDA Device · Class II · 2012-08-22 · Edwards Lifesciences
Reason: 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 catheter. - Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7J. For use in patients who require hemodynamic monitoring
FDA Device · Class II · 2012-08-22 · Edwards Lifesciences
Reason: 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 catheter. - Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151HF7. For use in patients who require hemodynamic monitoring
FDA Device · Class II · 2012-08-22 · Edwards Lifesciences
Reason: 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 catheter. - Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model TS057HF7. For use in patients who require hemodynamic monitoring
FDA Device · Class II · 2012-08-22 · Edwards Lifesciences
Reason: 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 catheter. - Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7J. For use in patients who require hemodynamic monitoring
FDA Device · Class II · 2012-08-22 · Edwards Lifesciences
Reason: 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 catheter. - Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7J. For use in patients who require hemodynamic monitoring
FDA Device · Class II · 2012-08-22 · Edwards Lifesciences
Reason: 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 catheter. - Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141F7. For use in patients who require hemodynamic monitoring
FDA Device · Class II · 2012-08-22 · Edwards Lifesciences
Reason: 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 catheter. - Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7P. For use in patients who require hemodynamic monitoring
FDA Device · Class II · 2012-08-22 · Edwards Lifesciences
Reason: 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 catheter. - Edwards Lifesciences Rigid Suction Wand, sterile
FDA Device · Class II · 2012-07-18 · Edwards Lifesciences
Reason: 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.