FDA Device recall Z-2602-2026
Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan
- FDA Device
- Class I
- ongoing
- Published 2026-07-01
On 2026-07-01 the FDA classified a Class I recall of Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan 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-2602-2026 |
| 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 Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542.
Reason
Potential for thrombus formation during prolonged use of the introducer.
Identifiers
| code_info | Impella Set Product Code: 1000542; GTIN: 813502013467; Serial numbers: N/A. Batch Number: 2041530. Introducer Product Code: 1000542; Batch Number: 2041530. |
|---|
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-2602-2026%22
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