Automated Impella Controllers recalled over alarm, power and purge cassette faults
Automated Impella Controllers sold outside the US are being recalled over alarm failures, power-path faults, electrical-short risks, inaccurate motor-current sensing and purge cassette misalignment.
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 death is reported in the source, so it does not escalate to Critical.
Plain-English summary
The Automated Impella Controller (AIC) is being recalled across several regional product codes, including Impella Controller, Packaged, CA (0042-0000-CA) and Impella Controller, Packaged, EU (0042-0000-EU). The action covers 625 units.
The recall is a retrospective submission covering identified issues. Alarm failures, power-path faults, electrical-short risks and inaccurate motor-current sensing were identified in certain AIC consoles. In addition, there is improper alignment between the purge cassette and the motor drive in the AIC, which can result in a piston block event. The FDA classified the action as Class I, its most serious classification.
Distribution was worldwide, covering the United States nationwide and Canada, Denmark, France and other markets. The controllers are used in hospitals to drive Impella heart pumps.
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) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged…
- Manufacturer
- Abiomed, Inc.
- Affected units
- 625
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-CA. GTIN: 00813502011272. Serial Numbers: IC1324
- IC1346
- IC1480
- IC1481
- IC1543
- IC1544
- IC1572
- IC1595
- IC1598
- IC1664
- IC1665
- IC1265
- IC1275
- IC1276
- IC1288
- IC1284
- IC1301
- IC1302
- IC1304
- IC1305
Distribution
Distributed nationwide across the United States.
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