Drug recall
HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU
FDA recall event 89966 · Class I · Medtronic Inc
Key facts
| Event ID | 89966 |
|---|---|
| Recall numbers | Z-1207-2022 |
| Recalling firm | Medtronic Inc |
| Product type | Devices |
| Products | HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | 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… |
| Initiation date | Apr 14, 2022 |
| Report date | Jun 15, 2022 |
| City | Minneapolis |
| State | MN |
| Country | United States |
| FEI number | 3001504994 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: