CLASS I Device recall · Reported 28 Aug 2019 · FDA Enforcement Report
Edwards Sapien 3 Ultra Transcatheter Heart Valve System recalled
Edwards Lifesciences is recalling Edwards Sapien 3 Ultra Transcatheter Heart Valve System (Sapien 3 Ultra Delivery System), distributed in 12 states. The recall was initiated on 9 Jul 2019 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2226-2019
- FDA event ID
- 83293
- Recalling firm
- Edwards Lifesciences, Irvine, CA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 9 Jul 2019
- FDA classified
- 21 Aug 2019
- Reported
- 28 Aug 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 9 Jul 2019 | Recall initiated by company | |
| 21 Aug 2019 | Classified by FDA | +43 days |
| 28 Aug 2019 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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 the system from the patient during procedures
Product as listed by the FDA
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (26mm) 9630TF26 UDI:00690103201253
Where it was distributed
US: VA, CA, GA, MA, MD, NY, OR, WA, MN, TN, AL, KS OUS: United Kingdom, Switzerland, Sweden, Spain, Portugal, Poland, Norway, Netherlands, Italy, Ireland, Germany, Finland, Denmark, Canary Islands, Canada, Austria
AlabamaCaliforniaGeorgiaKansasMassachusettsMarylandMinnesotaNew YorkOregonTennesseeVirginiaWashington
Questions about this recall
Is Edwards Sapien 3 Ultra Transcatheter Heart Valve System (Sapien 3 Ultra Delivery System) recalled?
Yes. Edwards Lifesciences recalled Edwards Sapien 3 Ultra Transcatheter Heart Valve System (Sapien 3 Ultra Delivery System) on 9 Jul 2019. The recall is Class I and its status is Terminated. Recall number Z-2226-2019.
Why was it recalled?
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 the system from the patient during procedures
Which lots are affected?
All Lots
Where was it sold?
US: VA, CA, GA, MA, MD, NY, OR, WA, MN, TN, AL, KS OUS: United Kingdom, Switzerland, Sweden, Spain, Portugal, Poland, Norway, Netherlands, Italy, Ireland, Germany, Finland, Denmark, Canary Islands, Canada, Austria
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |