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

HeartWare HVAD System Battery Charger AC Adapter The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patient — recall Z-1428-2020

U.S. FDA — Device Enforcement · United States · 2020-01-23 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1428-2020
Date of alert: 2020-01-23
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Heartware, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00888707001298

Reported risk: Potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVAD Controller power port.

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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.

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