FDA Device recall Z-2599-2026
Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434
- FDA Device
- Class I
- ongoing
- Published 2026-07-01
On 2026-07-01 the FDA classified a Class I recall of Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434 by Abiomed, citing potential for thrombus formation during prolonged use of the introducer.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2599-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2026-05-22 |
| Published | 2026-07-01 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Abiomed |
| Distribution | US |
Product
Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product Code: 1000434.
Reason
Potential for thrombus formation during prolonged use of the introducer.
Identifiers
| code_info | Impella Set Product Code: 1000434; GTIN: 00813502012996; Serial Numbers: N/A. Introducer Product Code: 1000434; Batch Number: 2038639. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2599-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.