Abiomed Recalls Impella Optical Controllers Due to Purge Flag Component Failure
Abiomed is recalling 1,422 Impella Optical Controllers because a purge flag component may fail, causing purge cassette recognition issues.
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 medical device with a functional defect that could impact patient care, but the source text explicitly states no injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Abiomed, Inc. is recalling 1,422 units of the Impella Optical Controller. The recall covers 487 units distributed in the United States and 935 units distributed internationally. The affected product is identified by specific product codes and serial numbers listed in the official recall notice.
The recall is being conducted due to a potential failure of the purge flag component within the purge pressure sensor assembly. This failure may result in purge cassette recognition issues. The source text does not report any illnesses, injuries, or deaths associated with this defect.
The affected units were distributed nationwide in the United States and in numerous international markets, including Canada, the United Kingdom, Australia, and various countries in Europe, Asia, and the Middle East. Healthcare providers and facilities should check their inventory against the provided serial numbers and contact Abiomed for instructions on how to proceed.
The recalled product
- Product
- Impella Optical Controller with the below product descriptions and corresponding Product Codes. 1. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU. 2. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 3. Impella Optical Controller, Package
- Manufacturer
- Abiomed, Inc.
- Category
- Medical Device — Cardiac Support
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. Impella Optical Controller
- Packaged
- AU
- Product Code: 0042-0010-AU
- UDI-DI: 00813502010930
- Serial Numbers: IC5130
- IC5131
- 2. Impella Optical Controller
- EU
- Product Code: 0042-0010-EU
- UDI-DI: 00813502010961
- Serial Numbers: IC12955
- IC12978
- IC13013
- IC13027
- IC13042
- IC13202
- IC13223
- IC13228
- IC6947
Distribution
Distributed nationwide across the United States.
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