Abiomed Recalls

Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. Introducer Product Code: 1000435.

Potential for thrombus formation during prolonged use of the introducer.

Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Codes: 1000413, 1000834.

Potential for thrombus formation during prolonged use of the introducer.

Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542.

Potential for thrombus formation during prolonged use of the introducer.

Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product Code: 1000434.

Potential for thrombus formation during prolonged use of the introducer.

Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.

Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support.

Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, AU; Product Code:...

Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices.

Automated Impella Controller (AIC); Product Code: 0042-0000-US;

Abiomed Purge Cassette Recall 2026: 33,107 Impella Pump Sets Worldwide Over Purge Leaks

Increased risk of purge leaks with Generation 1 purge cassettes.

Abiomed Impella Automated Controller Recall 62 Units in 2026

Potential that the "Purge System Blocked" alarm display on the Automated Impella Controller (AIC) could be delayed when using first generation Impella 5.5 (0550-0008*) pumps.

Abiomed Impella RP Flex Recall 4,496 Devices Worldwide Over Sensor Drift (2026)

Abiomed recalled 4,496 Impella RP Flex with SmartAssist devices. The recall cites a differential pressure sensor that may malfunction and drift readings. Stop using the device immediately and follow the manufacturer's recall instructions.

Abiomed Impella RP with SmartAssist Recall Affects 291 Units Worldwide in 2026

Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.

Abiomed Impella RP Recall 179 Units for Sensor Drift Risk (2026)

Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.

Abiomed Recalls Impella 5.5 Devices Due to Packaging Error

Abiomed recalled two units of the Impella 5.5 with SmartAssist on December 4, 2025. The devices were packaged in incorrect outer cartons, posing a potential hazard. Patients and healthcare providers must stop using the devices immediately.

Abiomed Impella Controller Recall Aims to Address Cybersecurity Vulnerabilities Across 32 Product SK

Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller (AIC).

Abiomed Impella Automated Controller Recall Affects 9,177 Units Worldwide (2025)

Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures.

Abiomed Impella Controller AIC Recall 2025 Affects 71 Units Across 6 Regions

Specific Automated Impella Controllers (AICs) that have a Pump Driver Circuit Assembly do not meet current specifications. This may lead to decreased pump performance or pump stop and trigger an Impella Failure or Impella Stopped Controller Failure alarm.

Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller,...