Class II — BERLIN HEART GMBH
| Recalling firm | Berlin Heart, Inc. |
|---|---|
| Registered facility | BERLIN HEART, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures. |
| Product | EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01 |
| Quantity | 3 |
| Distribution | US Nationwide distribution in the states of MA, SC. |
| Initiated | 2026-04-24 |
| Classified | 2026-06-05 |
| Recall number | Z-2320-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — BERLIN HEART GMBH (Z-2320-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98797/
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