Device recall
Z-0946-2021: Medtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103, b. PUMP 1104, c…
FDA device recall · Class I · Heartware, Inc.
Key facts
| Recall number (Z-number) | Z-0946-2021 |
|---|---|
| Recall event | 86924 |
| Product | Medtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103, b. PUMP 1104, c. PUMP 1104JP, d. PUMP 1100, e. Model 1101, f. Model 1102, g. Model 1104CA-CLIN, h. Model 1205, i. Model MCS1705PU |
| Product code | DSQ |
| Recalling firm | Heartware, Inc. |
| Recall class | Class I |
| Status | Open, Classified |
| PMA numbers | P100047 |
| FEI number | 3007042319 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database