Every recall we track for Edwards Lifesciences, LLC — 58 in all — plus the complaints and injury reports the public filed about them.
Edwards Lifesciences recalls EVOQUE tricuspid delivery system REF:985:0690103D004EVD000V5 due to potential labeling issues if valve replacement is compromised. Affected patients should check their device lot numbers.
Edwards Lifesciences recalls Optisite Arterial Cannula model OPTI18 due to 3-4mm wire exposed that may cause injury during medical procedures.
Edwards recalls FEM-FLEXII Femoral Arterial Cannula model FEMII018AS due to exposed wire sections that may cause injury during medical procedures.
Edwards recalls FEM-FLEX II Femoral Arterial Cannula model FEMII016A due to exposed wire sections that could cause injury during medical procedures.
Edwards recalls FEM-FLEX II Femoral Arterial Cannula model FEMII018A due to exposed wire sections that may cause injury during medical procedures.
Edwards recalls FEM-FLEX II Femoral Arterial Cannula model FEMII016AS due to exposed wire sections that could cause injury during medical procedures.
Edwards Lifesciences recalls Optisite Arterial Cannula model OPTI16 due to 3-4mm wire exposed/protruding, which may cause injury during medical procedures.
Edwards Lifesciences recalls Acumen IQ Sensors with specific model numbers and lots due to potential flushing difficulties during pressure monitoring setup. Affected users should contact for remedy details.
Edwards Lifesciences recalls FloTrac Sensor with Vamp System (MHD6AZ, MHD6AZ5, MHD6C502) for potential flushing difficulties during pressure monitoring setup. Affected units have specific lot numbers and require medical use only.
Edwards Lifesciences recalls TruWave Vamp System Pressure monitoring sets with potential flushing difficulties during setup. Affected models include PXAVMP and variants with specific sizes and UDI lots. No remedy specified in recall notice.
Edwards Lifesciences recalls FloTrac Sensor models MHD8, MHD85, MHD6R5, MHD8R, MHD8R5, MHD8S, and STERILEEO for potential flushing difficulties during pressure monitoring setup. Affected units have specific UDI and lot numbers.
Edwards Lifesciences recalls TruWave Pressure monitoring sets with potential flushing difficulties during setup with pressure transducer. Affected models include PX212, PX260, PX272, PX284, and others. Contact for remedy details.
Edwards Lifesciences recalls Acumen IQ Sensor with VAMP System (REFs AIQS6AZ & AIQS6AZ5) for potential flushing difficulties during pressure monitoring setup. This device is used for intravascular pressure monitoring and requires a prescription.
Edwards Lifesciences recalls Fogarty Thru-Lumen Embolectomy Catheters with REF 12TLW805F35 due to potential slow balloon deflation (over 15 seconds) during use.
Edwards Lifesciences recalls PASCAL Precision Transcatheter Valve Repair System models 20000ISM and 20000IS due to potential resistance when releasing implants, which could cause improper rotation or additional implantation.
Edward Lifesciences recalls Swan-Ganz Combo V catheters with possible bent distal ends causing monitor errors. Affected units have specific lot numbers and exterior diameter 8F.
Edward Lifesciences recalls Swan-Ganz Combo V catheters with possible monitor error messages due to bent distal ends. Affected units have specific model and lot numbers.
Edwards Lifesciences recalls specific Fogarty Biliary Balloon Probes due to latex deterioration complaints. Affected models include 410235FP, 410405FP, and 410236FP with listed lot numbers. Consumers should check their product details.
Edwards Lifesciences recalls Fogarty Arterial Embolectomy Catheters with specific model numbers and lot numbers due to confirmed latex deterioration complaints. Affected units may have increased risk of allergic reactions or other complications.
Edwards Lifesciences recalls FORE-SIGHT ELITE Tissue Ox: Inaccurate oxygen readings in arms/legs may lead to incorrect medical treatment. Affected units have specific serial numbers and model references.
Edwards Lifesciences recalls Fore-Sight Elite Absolute Tissue Oximeters with model 01-06-3000 due to potential inaccurate low oxygen readings in arms/legs, which could lead to unintended medical treatments.
Edwards Lifesciences recalls PediaSat Oximetry Catheter Kit (REF XT358SJ) due to potential internal leaks. This may cause complications during medical use. Affected units have specific lot numbers and are not distributed in the US.
Edwards Lifesciences recalls PediaSat Oximetry Catheter Set (REF: XT358KTP) due to potential internal leaks. Affected units have specific lot numbers and dimensions. Consumers should contact Edwards for details.
Edwards Lifesciences recalls PediaSat Oximetry Catheter Kit (REF: XT3515SP) due to potential internal leaks. Affected units have specific lot numbers and dimensions. Consumers should contact Edwards for details.
Edwards Lifesciences recalls PediaSat Oximetry Catheter Kit (REF XT3515KTP) due to potential internal leaks. Affected units have specific lot numbers and dimensions. Consumers should check their product details and follow official instructions.
Edwards Lifesciences recalls PediaSat Oximetry Catheter Sets with potential internal leaks. Affected units have specific model and lot numbers. Consumers should contact Edwards for details.
Edwards Lifesciences recalls PediaSat Oximetry Catheter Sets with potential internal leaks. Affected units have specific model and lot numbers. Contact for return instructions.
Edwards recalls specific TruWave pressure monitoring kits due to potential tubing detachment from blood sampling systems. Affected kits have REF PXVJ356 and lots 63505216/63590: stop using immediately to prevent injury.
Edwards recalls specific TruWave pressure monitoring kits due to potential tubing detachment from blood sampling systems. Affected kits have a unique reference number and lot code. Contact Edwards for details.
Edwards recalls TruWave (30 cc)/VAMP Jr/52 in (132 cm) Pressure Monitoring Kit due to potential pressure tubing detachment from blood sampling systems. Affected units have specific lot numbers and were sold with CE marking.
Edwards recalls TruWave (3 cc)/VAMP Jr Pressure Monitoring Sets with potential tubing detachment. Affected units have specific CE UDI and lot numbers. Contact for remedy.
Edwards Lifesciences recalls blood management systems with potential pressure tubing detachment. Affected units have specific UDI and lot numbers. Stop using immediately to prevent injury.
Edwards Lifesciences recalls VAMP Jr. 6 in blood management systems with potential pressure tubing detachment. This device is for medical use only and requires immediate attention.
Edwards recalls TruWave 3 cc/VAMP Jr Kit (REF: VMP426PX) due to potential pressure tubing detachment from blood sampling systems. Affected units have CE UDI: (01)57460691950547 and lot # 63598812.
Edwards recalls specific pressure monitoring kits for potential tubing detachment during blood sampling. This recall applies to CE-marked kits sold outside the US with UDI 01 57460691930174. No action is required as the kits are not marketed in the US.
Edwards Lifesciences recalls Sterile Oxymetry Oligon Catheter Kit (model XA3816SFKT) due to compromised packaging. Affected units have specific lot codes. Consumers should check their kit for packaging issues.
Edwards Lifesciences recalls QuickDraw Venous Cannula models QD22 and QD25 due to risk of blood loss if used longer than 6 hours, especially during ECMO. Affected units have specific UDI numbers.
Edwards Lifesciences recalls specific EZ Glide aortic cannula models due to potential separation during cardiopulmonary bypass, risking significant blood loss. Affected units have unique identifiers and lot numbers.
Edwards Lifesciences recalls specific oxymetry cables due to inconsistent crimping causing intermittent communication issues. Affected cables have listed serial numbers; stop using if you own one.
Edwards recalls SAPIEN 3 Ultra Transcatheter Heart Valve System (20mm) due to burst balloons causing retrieval issues during procedures. Affected units have UDI:00690103201239; all lots.
Edwards recalls SAPIEN 3 Ultra 26mm heart valve systems with burst balloons that cause difficulty retrieving the device during procedures. Affected units have UDI:00690103201253; all lots.
Edwards recalls SAPIEN 3 Ultra Transcatheter Heart Valve System (23mm) due to burst balloons causing difficulty retrieving the device during procedures. Affected units have UDI:00690103201246; all lots.
Edwards recalls SAPIEN 3 Ultra Transcatheter Heart Valve System (29mm) due to burst balloons causing difficulty retrieving the device during procedures. Affected units have UDI:00690103201260; all lots.
Edwards Lifesciences recalls IntraClude intra-aortic occlusion devices due to potential balloon rupture during cardiopulmonary bypass, risking heart complications and requiring surgical changes.
Edwards Lifesciences recalls certain Fogarty Dilation Atrioseptostomy Catheters due to balloon deflation difficulties and fragmentation risks after deployment in pediatric heart procedures.
Edwards Lifesciences recalls Miller Balloon Atrioseptostomy Catheters with risk of balloon fragmentation after deployment. Affected units have REF: 830515F and expired within 15 months of 03/01/2019.
Edwards Lifesciences recalls EV1000A, EV1000NI, and EV1000CS monitors for potential fire risk from liquid entering AC power outlets. Affected units may need replacement.
Recall of Edwards Commander Delivery System models due to reported balloon component separation during TAVR procedures. Affected units include specific model numbers and UDI numbers.
Edwards Lifesciences recalls a limited number of IntraClude intra-aortic occlusion devices due to potential inter-lumen leaks between cardioplegia and pressure lumens, which could affect medical procedures.
Edwards Lifesciences recalls Swan Ganz Thermodilution Catheters with REF 131VF7P due to incorrect lumen assembly that may cause reversed pressure readings. Affected units were sold with lot number 61176314.
Edwards Lifesciences recalls Swan Ganz Thermodilution Catheters with incorrect lumen assembly (REF131F 7J) that may reverse pressure readings. Affected units have lot numbers 61321177 and 61227528. Contact for remedy.
Edwards Lifesciences recalls Swan Ganz Thermodilution Catheters with incorrect lumen assembly that may cause reversed pressure readings. Affected units have lot numbers 61176367 and 61176370. Contact for remedy.
Edwards Lifesciences recalls Swan Ganz Thermodilution Catheters (REF 131F7P) with incorrect lumen assembly that may cause reversed pressure readings. Affected units include specific lot numbers.
Edwards recalls SAPIEN 3 Transcatheter Heart Valve (Model 960: 26mm) due to incorrect valve size packaging. Affected units have specific serial numbers and use-by dates.
Edwards Lifesciences recalls IntraClude Intra-Aortic Occlusion Devices with possible leak at distal open end causing medical staff to add inflation fluid. Affected units include specific model numbers and lot numbers.
