Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product Code: 1000434.
Class I- Recalling firm
- Abiomed, Inc.
- Reason for recall
- Potential for thrombus formation during prolonged use of the introducer.
- Distribution pattern
- Worldwide - US Nationwide distribution in the states of FL, IL, MN, NJ, NY, VA and the country of Japan.
- State
- MA
- Status
- Ongoing
- Recall number
- Z-2599-2026
- Recall initiated
- May 22, 2026