⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

BERLIN HEART GMBH: EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01

Medical DevicesSource: FDA (device) · Date: 2026-06-17

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
BERLIN HEART GMBH
Product
EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01
Reason / hazard
Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the states of MA, SC.
Recall initiated
2026-04-24
Code info
REF/UDI-DI/serial number: P10P-001/04260090040102/2230714, 2230709; P30P-001x01/04260090040126/2230254
Product quantity
3
Voluntary mandated
Voluntary: Firm initiated
City
Berlin
State
N/A
Country
Germany
Event id
98797
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