Edwards Lifesciences, LLC recalls
Every recall we track for Edwards Lifesciences, LLC — 58 in all, from 2017–2026 — plus the complaints and injury reports the public filed about them. 1 is rated “stop using now”.
Recalls per year, by danger level
Recalls from Edwards Lifesciences, LLC peaked in 2021 (14); 58 since 2017. 2% rated “stop using now”.
All FDA recall records for Edwards Lifesciences, LLC since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 1 | 1 | 1 | 3 |
| 2018 | 0 | 4 | 2 | 0 | 6 |
| 2019 | 0 | 12 | 1 | 0 | 13 |
| 2020 | 0 | 0 | 1 | 0 | 1 |
| 2021 | 1 | 4 | 8 | 1 | 14 |
| 2022 | 0 | 0 | 4 | 0 | 4 |
| 2023 | 0 | 3 | 6 | 1 | 10 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 5 | 1 | 0 | 6 |
| 2026 (to date) | 0 | 0 | 1 | 0 | 1 |
Most common reasons for Edwards Lifesciences, LLC recalls
What to do if you have a recalled Edwards Lifesciences, LLC product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Edwards Lifesciences, LLC recalls
26 shown- Lower riskMedical device
Edwards Lifesciences, LLC recalls Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
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 LifesciencesMar 27, 2026 - Lower riskMedical device
Edwards Lifesciences, LLC recalls Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 Software
Edwards Lifesciences recalls Optisite Arterial Cannula model OPTI16 due to 3-4mm wire exposed/protruding, which may cause injury during medical procedures.
Edwards LifesciencesMay 14, 2025 - Lower riskMedical device
Edwards Lifesciences, LLC recalls Acumen IQ Sensor with VAMP System, REFs: AIQS6AZ & AIQS6AZ5, STERILEEO, Rx only. For use in intravascular pressure
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 LifesciencesOct 4, 2023 - Use cautionMedical device
Edwards Lifesciences, LLC recalls Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35
Edwards Lifesciences recalls Fogarty Thru-Lumen Embolectomy Catheters with REF 12TLW805F35 due to potential slow balloon deflation (over 15 seconds) during use.
Edwards LifesciencesSep 7, 2023 - Use cautionMedical device
Edwards Lifesciences, LLC recalls PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS
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.
Edwards LifesciencesJul 27, 2023 - Lower riskMedical device
Edwards Lifesciences, LLC recalls Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 7.5F
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 LifesciencesFeb 14, 2023 - Lower riskMedical device
Edwards Lifesciences, LLC recalls Fogarty Arterial Embolectomy Catheters Model Number: 120602FP 120403FP 120803FP 120404FP 120804FP 120805FP 120806FP
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 LifesciencesOct 6, 2022 - Lower riskMedical device
Edwards Lifesciences, LLC recalls FORE-SIGHT ELITE Absolute Tissue Oximeter, REF: 01-06-3000, Contents: Monitor 1 EA., Accessory Kit 1 EA.
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 LifesciencesMar 1, 2022 - Lower riskMedical device
Edwards Lifesciences, LLC recalls Edwards PediaSat Oximetry Catheter Set, REF: XT3515SJ, Exterior Diameter 5.5F, Usable Length 15 cm, Number of Lumens:
Edwards Lifesciences recalls PediaSat Oximetry Catheter Sets with potential internal leaks. Affected units have specific model and lot numbers. Contact for return instructions.
Edwards LifesciencesJul 9, 2021 - UnratedMedical device
Edwards Lifesciences, LLC recalls Edwards TruWave x 2 (3 cc)/VAMP Jr/54 in (136) Kit, REF: T443952B, Pressure Monitoring Set, RX Only, CE, Sterile EO,
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.
EdwardsMay 26, 2021 - Lower riskMedical device
Edwards Lifesciences, LLC recalls Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181
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 LifesciencesMar 27, 2020 - Use cautionMedical device
Edwards Lifesciences, LLC recalls QuickDraw Venous Cannula, REF: QD22, UDI: 00690103182699; and REF: QD25, UDI: 00690103182705
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 LifesciencesNov 27, 2019 - Use cautionMedical device
Edwards Lifesciences, LLC recalls EZ Glide Aortic Cannula, 24 Fr. (8.0mm) x 37.6 cm (14.8") 3/8" (9.5 mm) vented connector , RX Only, Sterile EC, Made in
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 LifesciencesOct 22, 2019 - Use cautionMedical device
Edwards Lifesciences, LLC recalls Oxymetry Cable, Rxonly. REF/UDI: HEMOXSC100/(01)00690103196986 - Product Usage: The HemoSphere oximetry cable is a
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 LifesciencesOct 7, 2019 - Use cautionMedical device
Edwards Lifesciences, LLC recalls Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (29mm) 9630TF29
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.
EdwardsJul 9, 2019 - Use cautionMedical device
Edwards Lifesciences, LLC recalls IntraClude Intra-Aortic Occlusion Device, REF: ICF100, 10.5 Fr (3.5 mm) X 39.4" (100 cm), Rx Only, Sterile EO The
Edwards Lifesciences recalls IntraClude intra-aortic occlusion devices due to potential balloon rupture during cardiopulmonary bypass, risking heart complications and requiring surgical changes.
Edwards LifesciencesMay 14, 2019 - Use cautionMedical device
Edwards Lifesciences, LLC recalls Edwards Lifesciences, Miller Balloon Atrioseptostomy Catheter, Sterile EO, Rx Only, REF: 830515F Product Usage: The
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 LifesciencesMar 28, 2019 - Use cautionMedical device
Edwards Lifesciences, LLC recalls EV1000 Clinical Platform, Models: EV1000A, EV1000NI, EV1000CS Product Usage: EV1000A Monitor is used to optimize fluid
Edwards Lifesciences recalls EV1000A, EV1000NI, and EV1000CS monitors for potential fire risk from liquid entering AC power outlets. Affected units may need replacement.
Edwards LifesciencesMar 21, 2019 - Use cautionMedical device
Edwards Lifesciences, LLC recalls Edward Lifesciences, Edwards Commander Delivery System: Model Number UDI Number 9600LDS20A (US) 00690103193930
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 LifesciencesJan 22, 2019 - Lower riskMedical device
Edwards Lifesciences, LLC recalls Edwards Lifesciences(R) IntraClude(TM) Intra-Aortic Occlusion Device is a 10.5 Fr (3.5mm), triple lumen, 100cm long
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 LifesciencesJan 16, 2019 - Lower riskMedical device
Edwards Lifesciences, LLC recalls Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131F7P (5 pack of 131F7) Product Usage: The Swan-Ganz
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 LifesciencesDec 21, 2018 - Lower riskMedical device
Edwards Lifesciences, LLC recalls Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm
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.
EdwardsJun 11, 2018 - Use cautionMedical device
Edwards Lifesciences, LLC recalls Edwards Lifesciences' IntraClude Intra-Aortic Occlusion Device. Packaged in a sterile barrier system. Model Number:
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.
Edwards LifesciencesMar 30, 2018 - UnratedMedical device
Edwards Lifesciences, LLC recalls Hemosphere System with the following three components: HEM1 Advanced Monitor, HEMSGM10 (Swan-Ganz Module), and
Edwards Lifesciences recalls Hemosphere System components due to software defects that may cause pre-procedural issues. Affected units include HEM1 Advanced Monitor, HEMSGM10 Swan-Ganz Module, and HEMOXSC100 Oximetry Smart Cable with specific serial numbers.
Edwards LifesciencesOct 2, 2017 - Use cautionMedical device
Edwards Lifesciences, LLC recalls Certitude Delivery System and any associated Multipacks Models - 9600CT20A, 9600CT23A, 9600CT26A, 9600CT29A Product
Edwards Lifesciences recalls Certitude Delivery System models 9600CT20A, 9600CT23A, 9600CT26A, 9600CT29A due to potential molding overflow defect that could detach during use and embolize into the patient.
Edwards LifesciencesJul 21, 2017 - Lower riskMedical device
Edwards Lifesciences, LLC recalls Fogarty Adherent Clot Catheter Model Numbers 1408010 and 140806 Product Usage: The Fogarty adherent clot catheters are
Edwards Lifesciences recalls Fogarty Adherent Clot Catheters with 6mm balloon size instead of 10mm. This may cause incomplete clot removal. Affected models 1408010 and 140806.
Edwards LifesciencesJul 6, 2017
Edwards Lifesciences, LLC recall questions
How many recalls has Edwards Lifesciences, LLC had?
58 recalls from Edwards Lifesciences, LLC are on record with U.S. safety agencies, from 2017–2026.
What is the most recent Edwards Lifesciences, LLC recall?
Edwards Lifesciences, LLC recalls Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO, dated Mar 27, 2026. Every Edwards Lifesciences, LLC recall is listed on this page, newest first.
Why are Edwards Lifesciences, LLC products recalled?
The most common reasons on record: There is a potential for internal leaks within catheters. (6).
What should I do if I have a recalled Edwards Lifesciences, LLC product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Edwards Lifesciences, LLC recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.