Automated Impella Controller Software Update Resolves Pump Recognition Issue
Abiomed is releasing software Version 8.5 for the Automated Impella Controller to fix an issue in versions 8.4 and 8.4.1 where the device failed to recognize the pump. Approximately 4,463 units were distributed nationwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall of a cardiovascular support device with a software defect affecting pump recognition. Although no injuries have been reported, the critical nature of the device and the functional defect warrant a High severity rating as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
The Automated Impella Controller (AIC) is a cardiovascular support device manufactured by Abiomed, Inc. Certain units with software versions 8.4 and 8.4.1 contained a defect where the controller failed to recognize the pump component of the Impella Ventricular Support System.
Abiomed has released software Version 8.5 through Technical Bulletin IMP-2643, which resolves the pump recognition issue. No injuries or illnesses have been reported.
Approximately 4,463 units were affected and distributed nationwide in the United States. Healthcare providers using the Automated Impella Controller should verify their device software version and implement the available software update by following the instructions in Technical Bulletin IMP-2643.
The recalled product
- Product
- Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular Support Systems (cardiovascular)
- Manufacturer
- Abiomed, Inc.
- Affected units
- 4,463
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- 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
Distribution
Distributed nationwide across the United States.
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