Quick Facts at a Glance
- Recall Date
- April 24, 2026
- Hazard Level
- HIGH
- Brand
- BERLIN HEART GMBH
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- BERLIN HEART GMBH
- Model numbers
- REF/UDI-DI/serial number: P10P-001/04260090040102/2230714, 2230709, P30P-001x01/04260090040126/2230254
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
April 24, 2026
Reported by FDA DEVICE
June 17, 2026
RecallRadar source check
June 23, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact BERLIN HEART GMBH or your healthcare provider for instructions. Notification method: Letter
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Full Description
EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01. Reason: 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. Quantity: 3. Distribution: US Nationwide distribution in the states of MA, SC.
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: How to Get Refunds and ReplacementsWant to Know First?
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