Abiomed Impella 5.5 Recall for Potential Shockwave Catheter Interaction
Abiomed is recalling 2,916 Impella 5.5 units to update labeling regarding a potential interaction with Shockwave Coronary IVL Catheters during coronary interventions.
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: The recall is classified as FDA Class II and involves a labeling update to address a potential device interaction without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Abiomed, Inc. is recalling 2,916 units of the Impella 5.5 with SmartAssist Set (Product Code: 0550-0008). The recall is being conducted to address a potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions.
Currently, Abiomed labeling, including the Instructions for Use (IFU), does not contain content related to this potential interaction. As part of the recall, Abiomed will update the IFU to include information regarding this potential device interaction.
The affected units were distributed worldwide, including in the United States and numerous international markets. No specific illnesses or injuries are reported in the source text. Healthcare providers and patients should be aware of this potential interaction when using these devices together.
The recalled product
- Product
- Impella 5.5 with SmartAssist Set, US; Product Code: 0550-0008;
- Manufacturer
- Abiomed, Inc.
- Category
- Medical Device — Cardiac Support
- Affected units
- 2,916
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: 0550-0008
- UDI-DI: 00813502011531
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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