Official recall notice
FDA DeviceClass INotable
FDA Recall: Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435.
- Recall date
- 2026-07-01
- Brand
- Abiomed, Inc.
- Category
- Medical Device
- FDA class
- Class I
Why it was recalled
Hazard
Potential for thrombus formation during prolonged use of the introducer.
Product description
Potential for thrombus formation during prolonged use of the introducer.
Affected products
Impella Set Product Code: 1000435; GTIN: 00813502013009; Serial Numbers: N/A. Introducer Product Code: 1000435; Batch Numbers: 2038707, 2045782.