Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Codes: 1000413, 1000834.
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-2601-2026
- Recall initiated
- May 22, 2026