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

Recall Z-2478-2021 — Medtronic HVAD Pump Implant Kits

U.S. FDA — Device Enforcement · United States · 2021-08-06 · 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-2478-2021
Date of alert
2021-08-06
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Heartware, Inc.
Product category
device
Product type
Devices
Reported risk: There is more force required to slide the driveline cover (boot cover) away from the connector after completion of a Driveline Strain Relief Repair than over an unrepaired strain relief. This may lead to difficulty in pulling back the driveline cover when attempting to access the Driveline connector during a controller exchange. Additionally, sliding the driveline cover over a strain relief repair may compromise the repair.
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.

Related

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.