Berlin Heart recalls pediatric ventricular assist device blood pump valves with mismatched expiration dates that could delay surgery. Affected units have specific reference numbers and serial codes.
Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.
Berlin Heart is recalling pediatric ventricular assist device blood pump valves that have mismatched expiration dates on the inner and outer packaging. This mismatch could delay critical surgical procedures for children needing heart support.
The blood pump valve's inner package expiration date does not match the outer package's expiration date. This mismatch could cause delays in surgical procedures if the device needs to be used during critical timeframes.
Children using pediatric ventricular assist devices (VADs) with the recalled blood pump valves are affected. Medical teams handling these devices during surgery are at higher risk due to potential delays.
Check for the reference numbers P10P-001 or P30P-001x01 on the blood pump valves. The serial numbers include codes like 04260090040102/2230714 or 04260090040126/2230254.
Verify that the inner package expiration date matches the outer package's expiration date on the blood pump valve.
The blood pump valve's inner package expiration date does not match the outer package's expiration date, which could delay critical surgical procedures.
The affected models are the 10 ml blood pump valve with reference P10P-001 and the 30 ml blood pump valve with reference P30P-001x01.
Check for reference numbers P10P-001 or P30P-001x01 on the blood pump valve, and look for serial numbers like 04260090040102/2230714 or 04260090040126/2230254.
We’ve drafted a message you can send Berlin Heart to request your refund or repair — edit it as you like.
Subject: Recall Z-2320-2026 — Berlin Heart Berlin Heart Hello, I own a Berlin Heart that is covered by recall Z-2320-2026 from Berlin Heart. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
