FDA recall, , Moderate risk
EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves
The blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.
Summary by Recall Canary from the FDA notice
What happened
Berlin Heart GmbH, based in Berlin, Germany, recalled its EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001, and 30 ml, REF: P30P-001x01, because the blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.
The recall began on April 24, 2026, and was added to the FDA's Enforcement Report on June 5, 2026. The devices were distributed nationwide in the states of Massachusetts and South Carolina.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01
- UDI-DI
- 04260090040102
- 04260090040126
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of Massachusetts, South Carolina.
- Company
- BERLIN HEART GMBHBerlin, Germany
- Hazard
- Labeling error
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98797
- Recall number
- Z-2320-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
