FDA•CRITICAL
Abiomed Impella RP Flex Introducer
Abiomed recalls Impella RP Flex introducers over sheath leakage risk.
13 productsAbiomed, Inc.
Abiomed, Inc.: 8 recalls listed since February 2026 across FDA; 8 rated CRITICAL.
By year
- 20268
By agency
- FDA8
By category
- Medical Device8
All recalls (8)
FDA•CRITICALAbiomed Impella CP Introducer KitAbiomed recalls Impella CP introducer kit (14 Fr x 13 cm) over thrombus risk.
4 products
FDA•CRITICALImpella CP Set with SmartAssistAbiomed is recalling Impella CP Sets with SmartAssist due to a risk of low purge pressure that may interrupt mechanical circulatory support.
FDA•CRITICALImpella Heart Pump Software RecallAbbott's Impella heart pumps may fail to restart after certain operational faults, posing a serious health risk to patients.
2 products
FDA•CRITICALAbiomed Automated Impella ControllerAbiomed is recalling the Automated Impella Controller due to hardware issues that may cause motor control, startup, or power failures.
FDA•CRITICALAbiomed Impella Purge CassetteAbiomed is recalling Generation 1 purge cassettes due to an increased risk of purge leaks.
2 products
FDA•CRITICALAbiomed Automated Impella ControllerAbiomed is recalling Automated Impella Controllers due to a potential delay in the "Purge System Blocked" alarm.
2 products
FDA•CRITICALImpella RP Flex with SmartAssistAbiomed recalls Impella RP Flex with SmartAssist due to sensor drift risk.
3 products