Impella CP Cardiac Assist Pump Lacks Shockwave Catheter Interaction Warning
Abiomed is updating labeling for Impella CP Smart Assist pumps to address a potential interaction with Shockwave Coronary IVL Catheters during coronary interventions. The interaction was previously undocumented in device labeling.
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 recall addresses missing labeling about a potential device interaction. No illnesses, injuries, or incidents have been reported. The remedy is a precautionary update to product labeling to inform healthcare providers about the theoretical interaction.
Plain-English summary
Abiomed is recalling 705 units of the Impella CP Smart Assist Set APAC due to missing labeling information about a potential device interaction.
A potential interaction may occur between the Impella CP Smart Assist pump and the Shockwave Coronary IVL Catheter during coronary interventions. Abiomed's product labeling did not previously include information about this interaction.
The affected devices have been distributed worldwide, including throughout the United States and to over 30 countries. Abiomed is updating the product Instructions for Use (IFU) to address the potential device interaction and will notify healthcare facilities and providers.
The recalled product
- Product
- Impella CP Smart Assist Set APAC; Product Code: 0048-0047;
- Manufacturer
- Abiomed, Inc.
- Affected units
- 705
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: 0048-0047
- UDI-DI: 00813502011944
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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