Automated Impella Controller May Fail to Detect Connected Pump
The Automated Impella Controller (AIC) for left heart support may not detect a connected Impella pump, potentially preventing proper device operation. Approximately 11,031 units are affected worldwide.
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 classification requires a minimum severity score of 4. No illnesses or injuries are reported in the source, but the AIC is critical for patients dependent on mechanical heart support, and a detection failure poses significant safety risk.
Plain-English summary
Abiomed, Inc. is recalling the Automated Impella Controller (AIC), a device used to control left heart support blood pumps. The AIC manages operation of the Impella pump, which provides mechanical cardiac support to patients with failing hearts. Multiple AIC variants across different markets are affected, with approximately 11,031 units recalled globally.
The AIC has a potential defect where it may fail to properly detect when an Impella pump is connected to the controller. This detection failure could prevent the device from operating correctly and providing necessary cardiac support to patients relying on the system.
The recall affects both standard and loaner Impella Controllers distributed worldwide, including the United States, Europe, Asia, and other regions. Healthcare facilities and patients with affected AIC units should contact Abiomed for guidance on remedy or replacement options.
Abiomed has provided specific product codes and serial numbers to identify affected units. Patients should consult with their healthcare providers regarding their device status and any necessary action.
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; Pr
- Manufacturer
- Abiomed, Inc.
- Hazard
- detection-failure
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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