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

Recall Z-2056-2020 — Heartware HVAD Pump Implant Kit, Product (REF) Number 1104

U.S. FDA — Device Enforcement · United States · 2020-04-03 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2056-2020
Date of alert
2020-04-03
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Heartware, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00888707002028
Reported risk: The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump.
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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