FDA Device recall Z-2193-2021
HeartWare HVAD Driveline Extension Cable, REF 100US
- FDA Device
- Class I
- ongoing
- Published 2021-08-18
On 2021-08-18 the FDA classified a Class I recall of HeartWare HVAD Driveline Extension Cable, REF 100US by Heartware, citing medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological advers….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2193-2021 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2021-06-03 |
| Published | 2021-08-18 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Heartware |
| Distribution | US |
Product
HeartWare HVAD Driveline Extension Cable, REF 100US
Reason
Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events and mortality associated with the system when compared to other commercially available left ventricular assist devices, as well as complaints that the internal pump may delay or fail to restart.
Identifiers
| code_info | GTIN: 00888707000024 All serial numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2193-2021%22
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