Class I — Medtronic Inc
| Recalling firm | Medtronic, Inc. |
|---|---|
| Registered facility | View this company's 53 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Ongoing |
| Reason | 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. |
| Product | HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU |
| Quantity | 21 pump implant kits |
| Distribution | Worldwide distribution - US Nationwide DE and TX. There was no military/government distribution. The countries of Germany and Japan. |
| Initiated | 2022-04-14 |
| Classified | 2022-06-03 |
| Recall number | Z-1207-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Medtronic Inc (Z-1207-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89966/
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