Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. Introducer Product Code: 1000435.
Potential for thrombus formation during prolonged use of the introducer.
Official details
- Category
- Medical device recall
- Status
- Ongoing
- Classification
- Class I
- Company or vendor
- Abiomed, Inc.
- Affected product
- Worldwide - US Nationwide distribution in the states of FL, IL, MN, NJ, NY, VA and the country of Japan.
- Risk or reason
- Potential for thrombus formation during prolonged use of the introducer.
- Remedy or action
- Impella Set Product Code: 1000435; GTIN: 00813502013009; Serial Numbers: N/A. Introducer Product Code: 1000435; Batch Numbers: 2038707, 2045782.
- Official ID
- Z-2600-2026