Automated Impella Controllers may not detect a connected Impella pump
The Automated Impella Controller, used with left heart support blood pumps, is being recalled because of a potential issue with the controller not detecting an Impella pump when it is connected. 11,031 units affected.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 injury is reported in the source, so it does not escalate to Critical.
Plain-English summary
The Automated Impella Controller (AIC), used in left heart support blood pumps, is being recalled across the packaged controller product codes listed in the recall notice, including 0042-0000-AU. The action covers 11,031 units, identified by the GTIN and serial numbers in the notice.
The stated reason is a potential issue with the Automated Impella Controller not detecting an Impella pump when it is connected. 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 and Brunei Darussalam among other markets. The controllers are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected units using the product codes, GTINs and serial numbers in the recall notice and follow the instructions issued by the manufacturer.
The recalled product
- Product
- 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 Controller, Packaged, CA; Product Code: 0042-0000-CA. 3. Impella Controller, Packaged, EU…
- Manufacturer
- Abiomed, Inc.
- Affected units
- 11,031
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)
- 1. Product Code: 0042-0000-AU
- GTIN Number: 813502010886
- Serial Numbers: IC7849
- IC7850
- IC7287
- IC7288
- IC7289
- IC7290
- IC6526
- IC6527
- IC6528
- IC6529
- IC6530
- IC6531
- IC5622
- IC5677
- IC5752
- IC5836
- IC5341
- IC5521
Distribution
Distributed nationwide across the United States.
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