Automated Impella Controller software error affects left ventricular support devices
Automated Impella Controllers are being recalled because of a potential software error when used with left ventricular Impella devices. 10,297 units are affected.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall, which the rubric floors at Severe; no death is reported in the source, so it does not escalate to Critical.
Plain-English summary
The Automated Impella Controller (AIC), for use with a left heart support blood pump, from Abiomed, Inc., is being recalled across the product codes listed in the recall notice, including 0042-0000-AU. The action covers 10,297 units running software versions 6.0.1, 6.0.2, 6.0.3, 7.1 and above.
The stated reason is a potential software error in the Automated Impella Controller when used in conjunction with left ventricular Impella devices. The FDA classified the action as Class I, its most serious classification.
Distribution was worldwide, including nationwide in the United States and to Australia, Austria, Belgium, Brazil, Canada, China and other markets. The controllers are used in healthcare facilities rather than sold to consumers.
Facilities should identify affected controllers using the product codes, GTINs, serial numbers and software versions in the recall notice and follow the instructions issued by Abiomed.
The recalled product
- Product
- 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: 0042-0000-AU. 2. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA.
- Manufacturer
- Abiomed, Inc.
- Affected units
- 10,297
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 (20)
- All products below with software versions 6.0.1
- 6.0.2
- 6.0.3
- 7.1 and above. 1. Product Code: 0042-0000-AU
- GTIN: 00813502010886
- Serial Numbers: IC5341
- IC5523
- IC5677
- IC6531
- IC5525
- IC6529
- IC5836
- IC5524
- IC7849
- IC7850
- IC7287
- IC7288
- IC7289
- IC7290
- IC6527
Distribution
Distributed nationwide across the United States.
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