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

Recall Z-1698-2015 — HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100, 1101,1102,1104,1104JP and 1205. Product Usage: For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure.

U.S. FDA — Device Enforcement · United States · 2015-04-29 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1698-2015
Date of alert: 2015-04-29
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: HeartWare Inc
Product category: device
Product type: Devices

Reported risk: HeartWare has received complaints relating to damage or bent connection pins within the power supply ports of the VAD controller.

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.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-1698-2015 — HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100, 1101,1102,1104,1104JP and 1205. Product Usage: For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure.

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