Abiomed Recalls Automated Impella Controllers Due to Firmware and Software Defects
Abiomed is recalling 3,322 Automated Impella Controllers worldwide due to firmware and software defects that affect pressure signal accuracy and system reliability.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a Class II medical device with defects affecting critical performance signals and alarms. Per the rubric, this is classified as High because it is a risk-of-harm product where specific injury or illness reports are not stated in the source text.
Plain-English summary
Abiomed, Inc. is recalling 3,322 units of the Automated Impella Controller (AIC) and related Impella Optical Controllers. The recall covers units distributed in the United States and several international markets, including Austria, Belgium, Canada, France, Germany, Hong Kong, Italy, Luxembourg, Poland, Spain, Switzerland, and the United Kingdom.
The recall is a retrospective report of issues that were remedied in 2019 through firmware and software patches. The identified defects include flaws in the optical bench (OPB) firmware V2.19, which affected the accuracy and stability of the pressure signal the AIC system relies on. Additionally, software defects caused unreliable or missing placement signals, unresponsive start Impella soft keys during disconnect/reconnect events, and false Position in Ventricle alarms in certain units.
Healthcare providers and facilities should verify their inventory against the specific product codes and serial numbers listed in the official recall notice. Affected units should be identified and managed according to Abiomed's instructions to ensure patient safety and device performance.
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.
- Category
- Medical Device — Cardiac Support
- Affected units
- 3,322
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)
- IC2380
- IC2331
- IC1721
- IC1593
- IC1587
- IC4911
- IC4231
- IC4232
- IC6844
- IC2221
- IC4628
- IC6474
- IC4502
- IC1398
- IC4055
- IC3816
- IC6810
- IC6812
- IC6449
- IC6469
Distribution
Distributed nationwide across the United States.
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