EXCOR Pediatric Ventricular Assist Device Blood Pumps — Class I medical device recall Z-1618-2023
Terminated recall by BERLIN HEART GMBH, reported 2023-05-31, distributed in AL, AZ, CA, CO, FL, GA, MA, MN…. There is a potential for a disruption in one or more of the triple layer membranes of the ventricular assist d
| Recall number | Z-1618-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BERLIN HEART GMBH, Berlin, N/A, Germany |
| Recall initiated | 2018-05-18 |
| Classified | 2023-05-24 |
| Reported by FDA | 2023-05-31 |
| Terminated | 2024-06-06 |
| Distributed | AL, AZ, CA, CO, FL, GA, MA, MN, NC, NY, OH, PA, SC, TX, UT, WI |
| Countries outside the US | CA |
| Quantity | 335 units |
| UPC / GTIN / UDI-DI | 04260090040010, 04260090040027, 04260090040102, 04260090040119, 04260090040126, 04260090040157 |
| Serial numbers | 1321159, 1420128, 1420129, 1420132, 1420134, 1420135, 1420137, 1420138, 1420139, 1420142, 1420143, 1420150, 1420153, 1420162, 1420164, 1420170, 1420179, 1420184, 1420196, 1420233, 1420234, 1420236, 1420238, 1420258, 1420274 and 315 more |
| Model numbers | P10P-001 |
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1618-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.