FDA DevicesClass I
Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Pro...
Published: July 1, 2026Recall ID: Z-2599-2026Category: devicesCountry: US
Reason for Recall / Hazard
Potential for thrombus formation during prolonged use of the introducer.
Product Description & Identification
Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product Code: 1000434.
Additional Source Details
| Field | Value |
|---|---|
| City | Danvers |
| State | MA |
| Event id | 99002 |
| Address 1 | 22 Cherry Hill Dr |
| Address 2 | N/A |
| Code info | Impella Set Product Code: 1000434; GTIN: 00813502012996; Serial Numbers: N/A. Introducer Product Code: 1000434; Batch Number: 2038639. |
| Postal code | 01923-2575 |
| Report date | 20260701 |
| Product type | Devices |
| Product quantity | 3 units |
| Reason for recall | Potential for thrombus formation during prolonged use of the introducer. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260522 |
| Initial firm notification | Letter |
| Center classification date | 20260625 |
Overview
- Recalling FirmAbiomed, Inc.
- StatusOngoing
- Risk LevelClass I
- DistributionWorldwide - US Nationwide distribution in the states of FL, IL, MN, NJ, NY, VA and the country of Japan.