Device recall
Z-1337-2021: Power Supply: 1. Medtronic HVAD Controller AC Adapter, Product Numbers: 1425AU…
FDA device recall · Class I · Heartware, Inc.
Key facts
| Recall number (Z-number) | Z-1337-2021 |
|---|---|
| Recall event | 87446 |
| Product | Power Supply: 1. Medtronic HVAD Controller AC Adapter, Product Numbers: 1425AU, 1425CA, 1425DE, 1425GB, 1425IL, 1425IT, 1425US, 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, 1430US 2. Medtronic HVAD Controller DC Adapter, Product Number: 1440 |
| 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