Reported May 31, 2023 · Terminated
EXCOR Pediatric Ventricular Assist Device Blood Pumps, Models
Berlin Heart GmbH
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: BERLIN HEART GMBH · Wiesenweg 10 · Berlin, N/A · N/A
Is this the product you have?
EXCOR Pediatric Ventricular Assist Device Blood Pumps, Models
5 of 5 products
| # | Product as published |
|---|---|
| 1 | P10P-001 (10 ml blood pump) |
| 2 | P15P-001 (10 ml blood pump) |
| 3 | P25P-001x01 (25 ml blood pump) |
| 4 | P30P-001x01 (30 ml blood pump), P50P-001 (50 ml blood pump) |
| 5 | P60P-001 (60 ml blood pump). Recall occurred in 2018, and was retrospectively reported. |
- Lot codes and dates
- P10P-001 (UDI-DI04260090040102)-
- Serial Numbers
111 of 111 codes
152008115201001520309152008715203451720280162017715203671520344162015916206961620699172027416206931620669172027917202761720329152003716201611620157162016916206201620649162066216206521620650172029816206641620622162066317202991520041162066616201781421365152001115200791520080152009815200991520316152031716201621620638162065416206681620671162069816206671620665162067015200381520339162069715203491520054162069117202771720275
- P15P-001 (UDI-DI04260090040157) -
- Serial Numbers
114 of 114 codes
152026715202681520459152027815202771620367172042317205491520393152025316203641620388162039616204561720386152046915204861520449152045815203921520477152048116202101620381162038716204291620430182009515202471520280152047616201991620207152027414212611520169142123418200741820075182009817204301820094152021315201811520176142127715201771520286152027914212731520282152025515202811820099162021915202911520264152026215202651620457
- P25P-001x01 (UDI-DI04260090040119)-
- Serial Numbers
162055916204861620496162054616205621620547162056014205091420510172047515205971720456152059615205981720455172046115205931620541162049716205851720473162023116204981520586152059016205971420525142052614204961420527142052814204941420533142053814205361620548152062016205431720468172048315205991720482162048514205671620587
- P30P-001x01 (UDI-DI04260090040126)-
- Serial Numbers
1520624172021216205261620518162050015206381620044162004217202101520102132115915201031520142152014316200181520137152062315201071620010162004616200491520129152065415201081620005152013215206561520125162050115201131520641162052715201331520135
- P50P-001 (UDI-DI04260090040010)-
- Serial Numbers
172024514201841420196172024714201791420134142015014201531420142142014314201621420164142017014201281720248142012914201391420132142013514201371420138
- P60P-001 (UDI-DI04260090040027)-
- Serial Numbers
1420238142025814202331420234142023615206921420292142029014202741420278
- Amount recalled
- 335 units
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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