Impella CP Smart Assist Set Recalled for Device Interaction Labeling Update
Abiomed is updating labeling for ImpellaCP SmartAssistSetAPAC to address a potential interaction with Shockwave Coronary IVL Catheters during coronary interventions. Eight units were distributed worldwide.
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: Class II recall with no reported injuries, illnesses, or confirmed incidents. The hazard is a potential device interaction that has not yet been observed to cause harm. The recall is precautionary and addresses the issue through labeling updates to the Instructions for Use.
Plain-English summary
Abiomed is recalling 8 units of the ImpellaCP SmartAssistSetAPAC cardiac support device distributed worldwide due to incomplete labeling.
A potential interaction has been identified between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps when used together during coronary interventions. The device's current labeling does not include information about this potential interaction.
Abiomed is updating the Instructions for Use (IFU) to include information about this potential device interaction. Healthcare providers should consult updated labeling before using these devices in combination with Shockwave catheters.
The recalled product
- Product
- ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302;
- Manufacturer
- Abiomed, Inc.
- Affected units
- 8
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: 1000302
- UDI-DI: 00813502012767
- Serial Numbers: 392664 392661 392660 392665 392666 392667 392668 392669
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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