- Recalling firm
- Abiomed, Inc.
- Reason for recall
- Potential for thrombus formation during prolonged use of the introducer.
- Affected products (lot / model / serial)
- Impella Set Product Code: 1000435; GTIN: 00813502013009; Serial Numbers: N/A. Introducer Product Code: 1000435; Batch Numbers: 2038707, 2045782.
- Units affected
- 17 units
- Distribution pattern
- Worldwide - US Nationwide distribution in the states of FL, IL, MN, NJ, NY, VA and the country of Japan.
- Firm location
- Danvers, MA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2600-2026
- Recall initiated
- May 22, 2026
- FDA classification date
- June 25, 2026
- FDA report date
- July 1, 2026
- FDA event ID
- 99002
- Last updated on HTM Vibe
- July 23, 2026