FDA recall Z-2281-2023

Product

Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323

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.

Key facts

Status

Ongoing

Initiation date

2023-06-29

Report date

2023-08-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Danvers, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2281-2023