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
Check against the official notice below — it lists the full affected range.
Berlin Heart GmbH recalled 335 EXCOR Pediatric Ventricular Assist Device blood pumps due to a potential for disruption in one or more of the triple layer membranes. The recall involved four models (P10P-001, P15P-001, P25P-001x01, and P30P-001x01) and affected units distributed to 17 U.S. states (Massachusetts, Texas, Wisconsin, California, South Carolina, Florida, Colorado, New York, Pennsylvania, North Carolina, Utah, Georgia, Minnesota, Ohio, Arizona, and Alabama) as well as Canada. The recall occurred in 2018 and was retrospectively reported.
The source record does not specify a remedy or what actions affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: Distribution to US states of MA, TX, WI, CA, SC, FL, CO, NY, PA, NC, UT, GA, MN, OH, AZ, AL, and Canada Quantity: 335 units Lot/code info: 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: ; 1520267 1520268 1520459 1520278 1520277 1620367 1720423 1720549 1520393 1520253 1620364 1620388 1620396 1620456 1720386 1520469 1520486 1520449 1520458 1520392 1520477 1520481 1620210 1620381 1620387 1620429 1620430 1820095 1520247 1520280 1520476 1620199 1620207 1520274 1421261 1520169 1421234 1820074 1820075 1820098 1720430 1820094 1520213 1520181 1520176 1421277 1520177 1520286 1520279 1421273 1520282 1520255 1520281 1820099 1620219 1520291 1520264 1520262 1520265 1620457 1720361 1620438 1720362 16
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.