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

Recall Z-1207-2022 — HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU

U.S. FDA — Device Enforcement · United States · 2022-04-14 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1207-2022
Date of alert
2022-04-14
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Medtronic Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00763000170967
Reported risk: The pump may have a welding defect that can lead the pump to malfunction. The issue is under investigation by the firm. It is suspected that a weld defect on the center post cap may allow moisture into the center post and corrode the magnets that keep the impeller rotating concentrically, leading to unintended contact between the center post and impeller. If this occurs, it may affect blood flow through the pump. The issue may present clinical signs and symptoms that resemble pump thrombosis.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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.