Temporary Non-roller Type Left Heart Support Blood Pump

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:

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

Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes.

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.

Automated Impella Controller (AIC);

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.

Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configurations and corresponding product codes.

Increased risk of purge leaks with Generation 1 purge cassettes.

Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes:

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.

Impella 5.5 with SmartAssist S2, Impella 5.5 with SmartAssist S2 Set, AU.

Device packaged in incorrect outer box carton.

Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes:

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

Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following with corresponding Product Codes:

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

Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist pump.

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.