Abiomed updates Impella CP labeling for Shockwave coronary catheter interaction
Abiomed is recalling the Impella CP Pump 371 Set due to a potential device interaction with the Shockwave Coronary IVL Catheter. The manufacturer is updating labeling to address this interaction. No illnesses or injuries have been reported.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses, injuries, or confirmed incidents. The hazard is characterized as 'potential' rather than confirmed, and the recall mechanism is a labeling update to prevent future risk. This fits the 'voluntary precautionary recall' criterion for a Moderate severity classification.
Plain-English summary
Abiomed, Inc. is recalling the Impella CP Pump 371 Set due to a potential device interaction with the Shockwave Coronary IVL Catheter that may occur during coronary interventions. The interaction specifically relates to use of left-sided Impella Pumps. Currently, the device labeling does not document this potential interaction.
The manufacturer is updating the product labeling and instructions for use to include information about this potential device interaction. The recall affects 9 units in the Impella CP Pump 371 Set distributed worldwide across the United States and 27 additional countries. No illnesses or injuries have been reported.
The recalled product
- Product
- Impella CP Pump 371 Set, Clinical Trial; Product Code: 0048-0040;
- Manufacturer
- Abiomed, Inc.
- Hazard
- device-interaction
- labeling-deficiency
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 (3)
- Product Code: 0048-0040
- UDI-DI: 00813502011739
- Serial Numbers: 370089 370091 370090 370074 370093 401804 401805 401811 401806
Distribution
Distributed nationwide across the United States.
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