Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542.
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-2602-2026
- Recall initiated
- May 22, 2026
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