EXCOR Pediatric Ventricular Assist Device — Class II medical device recall Z-2320-2026
Ongoing recall by BERLIN HEART GMBH, reported 2026-06-17, distributed nationwide. Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to d
| Recall number | Z-2320-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | BERLIN HEART GMBH, Berlin, N/A, Germany |
| Recall initiated | 2026-04-24 |
| Classified | 2026-06-05 |
| Reported by FDA | 2026-06-17 |
| Distributed | Nationwide (US) |
| Quantity | 3 |
| UPC / GTIN / UDI-DI | 04260090040102, 04260090040126 |
| Serial numbers | 2230709 |
| Model numbers | P10P-001, P30P-001X01 |
Product
EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01
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.
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-2320-2026. 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.