Abiomed, Inc.: Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323

Hazard

A higher than expected rate of thrombus formation or deposition has been observed. The risk is for thrombus formations or deposits on indwelling central venous lines or cannulas may break free and enter into the Impella RP Flex, resulting in reduced flow, loss of support, or hemolysis

Details from the source

Reason for recall: A higher than expected rate of thrombus formation or deposition has been observed. The risk is for thrombus formations or deposits on indwelling central venous lines or cannulas may break free and enter into the Impella RP Flex, resulting in reduced flow, loss of support, or hemolysis Distribution: US Nationwide distribution including in the states of AR, CA, FL, GA, LA, MA, MI, MO, NC, NJ, NY, OH, OR, SC, TX, and WI. Quantity: 166 units Lot/code info: UDI-DI: 00813502012811; Serial Numbers: 409541 409542 409544 411379 416645 416646 416647 416649 418933 418939 418940 419489 421953 421955 422974 422978 423999 425596 428726 428730 429616 429617 429623 429646 429648 429649 429650 429651 429652 429654 430363 430365 430366 430367 430923 430929 430931 431099 431106 431532 431535 431844 431846 431847 431848 431850 431868 431869 431870 432394 432395 432396 432397 432398 432400 432401 432402 432643 432644 432645 432648 432651 433755 433756 434540

UPC codes

00813502012811

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.