Impella CP Pump Set Recalled for Potential Device Interaction
Abiomed is recalling the Impella CP Pump Set due to a potential device interaction with the Shockwave Coronary IVL Catheter during coronary interventions. The manufacturer will update device instructions to address this interaction.
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: This is an FDA Class II recall for a potential device interaction during coronary interventions with no reported illnesses or injuries. Per the severity rubric, since the hazard is theoretical with no reported incidents, this qualifies as a risk-of-harm product where injury has not yet been reported, scoring 3 (High).
Plain-English summary
Abiomed, Inc. is recalling the Impella CP Pump Set (Product Code: 0048-0034-JP) due to a potential device interaction with the Shockwave Coronary IVL Catheter that may occur during coronary interventions. Currently, the manufacturer's labeling does not document this potential interaction.
The manufacturer will update the Instructions for Use (IFU) to include information about this device interaction. Four units were affected with serial numbers 324303, 323153, 328083, and 328085 (batch numbers 2022079852, 2022079846, 2022083745, and 2022083747). Distribution is worldwide, including the United States and numerous international markets.
The recalled product
- Product
- Impella CP Pump Set, Japan; Product Code: 0048-0034-JP;
- Manufacturer
- Abiomed, Inc.
- Hazard
- device-interaction
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 (4)
- Product Code: 0048-0034-JP
- UDI-DI: 00813502011463
- Serial Numbers: 324303 323153 328083 328085
- Batch Numbers: 2022079852 2022079846 2022083745 2022083747
Distribution
Distributed nationwide across the United States.
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