Recall
Get alerts

abiomed, inc.

18 recalls on record

Get alerts
A
Abiomed, Inc. — 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.

A
Abiomed, Inc. — 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.

A
Abiomed, Inc. — 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.

A
Abiomed, Inc. — 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.

A
Abiomed, Inc. — 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.

A
Abiomed, Inc. — 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; Pro

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

A
Abiomed, Inc. — Automated Impella Controller (AIC); Product Code: 0042-0000-US;

A retrospective review identified that there are AIC units requiring specific hardware updates to address potential safety concerns. These hardware updates have been implemented through Abiomed s servicing process; therefore, AICs that have not received service are pending these updates. Issue 1: The proximity of the internal Video Graphics Array cable to the Digital Signal Processor chipset on the Impellatronic printed circuit assembly could potentially result in Electrostatic Discharge coupling into the Digital Signal Processor which may interrupt motor controls. Issue 2: There is a potential for the Compact Flash Memory Card dislodgement due to external applied forces, which could result in AIC startup failures and data logging issues. Issue 3: Improper routing of the fan wire within the AIC could lead to fan wire damage, which may result in console boot-up failure. Issue 4: Potential capacitor related issues on the Power Battery Manager, including the potential for the capacitors to cause pump stop, purge stop, and/or single fan fuse failures.

A
Abiomed, Inc. — Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configurations and corresponding product codes. 1. Purge Cassette, 5 Pa

Increased risk of purge leaks with Generation 1 purge cassettes.

A
Abiomed, Inc. — Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Contr

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.

A
Abiomed, Inc. — Impella RP. Product Code: 0046-0011.

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

A
Abiomed, Inc. — Impella RP with SmartAssist. Product Code: 0046-0035.

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

A
Abiomed, Inc. — Impella RP Flex with SmartAssist. Product Code: 1000323.

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

A
Abiomed, Inc. — Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.

Device packaged in incorrect outer box carton.

A
Abiomed, Inc. — Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, AU; Product Cod

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

A
Abiomed, Inc. — Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect for ECP, Product Code: 1000432. 2. Dbl optical, AIC Impella Con

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

A
Abiomed, Inc. — Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist pump. 1. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 2. Impella

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.

A
Abiomed, Inc. — Automated Impella Controller (AIC), used in left heart support blood pump, including the following: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impella

A potential issue with the Automated Impella Controller (AIC) not detecting an Impella pump when it is connected

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

Retrospective submission for following issues identified: 1. Alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing were identified in certain AIC consoles. 2. There is improper alignment between the purge cassette and the motor drive in the AIC. This can result in a piston block event and lead to the inability to complete priming of the purge system, requiring the user to switch to backup AIC console.