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

Recall Z-0747-2023 — HeartWare HVAD Pump Kit, REF 1104CA-CLIN

U.S. FDA — Device Enforcement · United States · 2022-11-29 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0747-2023
Date of alert
2022-11-29
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Heartware, Inc.
Product category
device
Product type
Devices
Reported risk: Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline connector may be delayed, which may result in patient harm from a prolonged pump stop, if an urgent driveline connection or controller issue needs to be addressed. In the event a hardened driveline cover is observed, contact your Medtronic field representative for further assessment and/or servicing.
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.