Recalling firm
BERLIN HEART GMBH
Product type
Device
Status
Ongoing
Report date
2026-06-17
Distribution
US Nationwide distribution in the states of MA, SC.
Firm state
N/A
Product quantity
3
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & QualificationReason for recall
Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.
Product description
EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01
Code / lot info
REF/UDI-DI/serial number: P10P-001/04260090040102/2230714, 2230709; P30P-001x01/04260090040126/2230254
Other recalls SPEQ maps to Validation & Qualification
See all Validation & Qualification recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.