Abiomed, Inc.: Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular Support Systems (cardiovascular)

Is my product affected?

Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular Support Systems (cardiovascular)

• UPC 00813502010022
• UPC 00813502010985
• UPC 00813502011401

Check against the official notice below — it lists the full affected range.

What happened

Abiomed, Inc. is conducting a retrospective recall of its Automated Impella Controller (AIC) devices distributed nationwide in the United States. The recall involves approximately 4,463 units with product codes 0042-0000-US, 0042-0010-US, and 0042-0040-US running software versions V8.4 and V8.4.1. The devices were recalled following the release of Technical Bulletin IMP-2643, which announced a software update to version 8.5.

The issue addressed by the software update was that a pump was not being recognized by the AIC in version 8.4. The recall record does not specify a remedy or action that affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Retrospective reporting for the release of Technical Bulletin IMP-2643 AIC Version 8.5 Software Update Available. The update resolved an issue in version 8.4 where a pump was not recognized by the AIC.

Details from the source

Reason for recall: Retrospective reporting for the release of Technical Bulletin IMP-2643 AIC Version 8.5 Software Update Available. The update resolved an issue in version 8.4 where a pump was not recognized by the AIC. Distribution: US Nationwide distribution. Quantity: 4,463 (US) Lot/code info: Product Code 0042-0000-US UDI-DI 00813502010022; Product Code 0042-0010-US UDI-DI 00813502010985; Product Code 0042-0040-US UDI-DI 00813502011401; Software Versions V8.4 and V8.4.1

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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