- Recalling firm
- Abiomed, Inc.
- Reason for recall
- Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support.
- Affected products (lot / model / serial)
- GTIN: 00813502012279. Product Codes (Serial Number): 1000080 (677223, 672986, 673252, 644591, 645428, 644314, 613525), 1000851 (636173), 0048-0014 (499250), 0048-0024-JP (661216).
- Units affected
- 10 units
- Distribution pattern
- US distribution to GA, IA, NE, PA, TX, WA, WI. International distribution to Czech Republic, Norway, and 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-2457-2026
- Recall initiated
- May 18, 2026
- FDA classification date
- June 18, 2026
- FDA report date
- June 24, 2026
- FDA event ID
- 98946
- Last updated on HTM Vibe
- July 23, 2026