Recall Z-2281-2023 ยท PYX Temporary Non-Roller Type Right Heart Support Blood Pump
Abiomed, Inc.
Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323
| Date | Aug 3, 2023 (initiated Jun 29, 2023) |
| Status | Open, Classified |
| Reason | 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 |
| Root cause | Under Investigation by firm |
| Action | An URGENT: MEDICAL DEVICE CORRECTION (NOTIFICATION) letter dated 6/29/23 was sent to customers. RECOMMENDATIONS: To minimize risk of thrombus formation or deposition, the following is recommended: " Maintenance of systemic anticoagulation (ACTs of 160-180 seconds) in particular when indwelling central venous lines (i.e., hemodialysis, PA catheters) are present, for the duration of Impella RP Flex with SmartAssist support as clinically feasible. " Assess the risk for extraluminal thrombus on indwelling lines (i.e., hemodialysis catheters, PA catheters) placed prior to initiation of support. " |
| Quantity | 166 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.