Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Cod
Pending LLM rewrite. Source: FDA_DEVICE Z-2238-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
Retrospective submission for following issues identified: 1. Alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing were identified in certain AIC consoles. 2. There is improper alignment between the purge cassette and the motor drive in the AIC. This can result in a piston block event and lead to the inability to complete priming of the purge system, requiring the user to switch to backup AIC console.
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, UK
- Manufacturer
- Abiomed, Inc.
- Category
- Medical Device — Devices
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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