Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System — Class I medical device recall Z-2226-2019
Terminated recall by Edwards Lifesciences, LLC, reported 2019-08-28, distributed in AL, CA, GA, KS, MA, MD, MN, NY…. The action has been initiated to address reports of burst balloons which have resulted in significant difficul
| Recall number | Z-2226-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Edwards Lifesciences, LLC, Irvine, CA, United States |
| Recall initiated | 2019-07-09 |
| Classified | 2019-08-21 |
| Reported by FDA | 2019-08-28 |
| Terminated | 2020-09-15 |
| Distributed | AL, CA, GA, KS, MA, MD, MN, NY, OR, TN, VA, WA |
| Countries outside the US | AT, CA, CH, DE, DK, ES, FI, GB, IE, IT, NL, NO, PL, PT, SE |
| Quantity | 2,579 units |
| UPC / GTIN / UDI-DI | 00690103201253 |
Product
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (26mm) 9630TF26 UDI:00690103201253
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2226-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.