BERLIN HEART recalls pediatric blood pumps (models P10P-001 to P60P-001) due to potential membrane disruption. This 2018 retrospective recall affects specific serial numbers.
There is a potential for a disruption in one or more of the triple layer membranes of the ventricular assist device. Recall occurred in 2018, and was retrospectively reported.
BERLIN HEART is recalling pediatric ventricular assist device blood pumps that could have membrane disruptions. This risk may cause device failure, but the recall is retrospective and occurred in 2018.
The pumps have a potential for disruption in one or more of their triple layer membranes, which could lead to device failure. This is a design issue that may not cause immediate harm but requires monitoring.
Patients using the recalled pediatric blood pumps (models P10P-001 to P60P-001) with specific serial numbers listed in the recall. Children with heart conditions requiring these devices are most at risk.
Check if your pump model is P10P-001, P15P-001, P25P-001x01, P30P-001x01, P50P-001, or P60P-001. Look for the specific serial numbers listed in the recall notice.
Identify your pump model from the list: P10P-001, P15P-001, P25P-001x01, P30P-001x01, P50P-001, or P60P-001.
Compare your pump's serial number against the list of affected numbers provided in the recall notice.
The recall was issued in 2018 as a retrospective action due to a potential for membrane disruption in the triple layer membranes of the pumps.
No, the recall does not require immediate discontinuation. The hazard is a potential membrane disruption that may not cause immediate harm.
Check your pump model against the list (P10P-001 to P60P-001) and verify your serial number against the provided list of affected numbers.
We’ve drafted a message you can send BERLIN HEART to request your refund or repair — edit it as you like.
Subject: Recall Z-1618-2023 — BERLIN HEART BERLIN HEART Hello, I own a BERLIN HEART that is covered by recall Z-1618-2023 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.
