FDA Device recall Z-1618-2023
EXCOR Pediatric Ventricular Assist Device Blood Pumps, Models: P10P-001 (10 ml blood pump)
- FDA Device
- Class I
- terminated
- Published 2023-05-31
On 2023-05-31 the FDA classified a Class I recall of EXCOR Pediatric Ventricular Assist Device Blood Pumps, Models: P10P-001 (10 ml blood pump) by Berlin Heart, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1618-2023 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2018-05-18 |
| Published | 2023-05-31 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Berlin Heart |
| Distribution | AL, AZ, CA, CO, FL, GA, MA, MN, NC, NY, OH, PA, SC, TX, UT, WI |
Product
EXCOR Pediatric Ventricular Assist Device Blood Pumps, Models: P10P-001 (10 ml blood pump); P15P-001 (10 ml blood pump); P25P-001x01 (25 ml blood pump); P30P-001x01 (30 ml blood pump), P50P-001 (50 ml blood pump); P60P-001 (60 ml blood pump). Recall occurred in 2018, and was retrospectively reported.
Reason
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.
Identifiers
| code_info | P10P-001 (UDI-DI: 04260090040102)- Serial Numbers: 1520081 1520100 1520309 1520087 1520345 1720280 1620177 1520367 15…P10P-001 (UDI-DI: 04260090040102)- Serial Numbers: 1520081 1520100 1520309 1520087 1520345 1720280 1620177 1520367 1520344 1620159 1620696 1620699 1720274 1620693 1620669 1720279 1720276 1720329 1520037 1620161 1620157 1620169 1620620 1620649 1620662 1620652 1620650 1720298 1620664 1620622 1620663 1720299 1520041 1620666 1620178 1421365 1520011 1520079 1520080 1520098 1520099 1520316 1520317 1620162 1620638 1620654 1620668 1620671 1620698 1620667 1620665 1620670 1520038 1520339 1620697 1520349 1520054 1620691 1720277 1720275 1720341 1520055 1520068 1520302 1520343 1520362 1520301 1520318 1520336 1520337 1520355 1421364 1720330 1720351 1620653 1620655 1520036 1520035 1520016 1520017 1520387 1520334 1520371 1620695 1520031 1520033 1520032 1620694 1520026 1520027 1520352 1520347 1620163 1520018 1520333 1520321 1520348 1620621 1720342 1720343 1520354 1421373 1520042 1520050 1520365 1520350 1720331 1520342 1520366 1520381 1520380; P15P-001 (UDI-DI: 04260090040157) - Serial Numbers: ; 15 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1618-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.