Automated Impella Controller Recalled for Electrical and Mechanical Faults
Abiomed is recalling 625 units of the Automated Impella Controller due to alarm failures, electrical faults, and mechanical misalignment that may prevent proper device function.
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: This is an FDA Class I recall, which mandates a minimum severity score of 4. The identified defects in alarm systems, electrical pathways, and mechanical alignment directly affect the safety and functionality of a critical cardiac assist device.
Plain-English summary
Abiomed, Inc. is recalling 625 units of the Automated Impella Controller (AIC) due to multiple electrical and mechanical defects identified in certain consoles.
The recalled devices may exhibit alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing. Additionally, improper alignment between the purge cassette and the motor drive can cause a piston block event, preventing completion of the purge system priming sequence and requiring use of a backup device.
The affected units have been distributed worldwide, including to the United States, Canada, Denmark, France, Germany, Italy, Kuwait, Netherlands, Norway, Saudi Arabia, Spain, Switzerland, the United Kingdom, and the United Arab Emirates. Specific model codes and serial numbers for all affected units are provided in the FDA recall notice.
Healthcare facilities that use these devices should contact Abiomed, Inc. to verify whether they have affected units based on the provided serial numbers and follow the manufacturer's remediation plan.
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.
- Hazard
- alarm-failure
- electrical-short
- power-path-fault
- sensor-failure
- mechanical-misalignment
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.
Related recalls
Same category
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03