Impella CP Smart Assist Set: Device interaction safety labeling update
Abiomed is updating labeling for the Impella CP Smart Assist Set to address a potential device interaction with the Shockwave Coronary IVL Catheter during coronary procedures. No illnesses or injuries have been reported.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 FDA Class II medical device recall involves a labeling deficiency regarding a potential device interaction. The source text explicitly states no illnesses or injuries have been reported, and the remedy is a labeling update rather than a device recall. The hazard is theoretical rather than confirmed, meeting the criteria for Moderate severity.
Plain-English summary
The Impella CP Smart Assist Set, manufactured by Abiomed, is a mechanical circulatory support device used during coronary interventions. A potential device interaction has been identified between the left-sided Impella Pump and the Shockwave Coronary IVL Catheter when used together during coronary procedures.
Abiomed has determined that current labeling for the Impella CP Smart Assist Set does not contain information about this potential device interaction. The manufacturer is updating the Instructions for Use (IFU) to include guidance on this interaction.
To date, no illnesses or injuries related to this potential interaction have been reported. Patients and healthcare providers should await the updated labeling for guidance on safe use of these devices in combination.
The recalled product
- Product
- Impella CP Smart Assist Set, EU; Product Code: 0048-0014;
- Manufacturer
- Abiomed, Inc.
- Affected units
- 17,837
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 (2)
- Product Code: 0048-0014
- UDI-DI: 04260113630280
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 18 recalled by Abiomed, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 18 products in this recall →Related recalls
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