Class I — BERLIN HEART GMBH
| Recalling firm | Berlin Heart, Inc. |
|---|---|
| Registered facility | BERLIN HEART, INC. (the firm's only registered facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | There is a potential for a disruption in one or more of the triple layer membranes of the ventricular assist device. Recall occurred in 2018, and was retrospectively reported. |
| Product | EXCOR Pediatric Ventricular Assist Device Blood Pumps, Models: P10P-001 (10 ml blood pump); P15P-001 (10 ml blood pump); P25P-001x01 (25 ml blood pump); P30P-001x01 (30 ml blood pump), P50P-001 (50 ml blood pump); P60P-001 (60 ml blood pump). Recall occurred in 2018, and was retrospectively reported. |
| Quantity | 335 units |
| Distribution | Distribution to US states of MA, TX, WI, CA, SC, FL, CO, NY, PA, NC, UT, GA, MN, OH, AZ, AL, and Canada |
| Initiated | 2018-05-18 |
| Classified | 2023-05-24 |
| Terminated | 2024-06-06 |
| Recall number | Z-1618-2023 |
| 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 I recall — BERLIN HEART GMBH (Z-1618-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/92132/
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