- Recalling firm
- BERLIN HEART GMBH
- Reason for recall
- Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.
- Affected products (lot / model / serial)
- REF/UDI-DI/serial number: P10P-001/04260090040102/2230714, 2230709; P30P-001x01/04260090040126/2230254
- Units affected
- 3
- Distribution pattern
- US Nationwide distribution in the states of MA, SC.
- Firm location
- Berlin, N/A, Germany
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2320-2026
- Recall initiated
- April 24, 2026
- FDA classification date
- June 5, 2026
- FDA report date
- June 17, 2026
- FDA event ID
- 98797
- Last updated on HTM Vibe
- July 23, 2026