Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2227-2019 — Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (29mm) 9630TF29 UDI:00690103201260

U.S. FDA — Device Enforcement · United States · 2019-07-09 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2227-2019
Date of alert
2019-07-09
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Edwards Lifesciences, LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00690103201260
Reported risk: 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
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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