Abiomed Recalls Impella 5.5 Sets Due to Potential Shockwave Catheter Interaction
Abiomed is recalling 20 Impella 5.5 Set AU units because there is no labeling information regarding a potential interaction with Shockwave Coronary IVL Catheters.
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: The recall is classified as FDA Class II, and the source text describes a lack of labeling regarding a potential interaction without reporting any specific injuries, illnesses, or deaths, fitting the criteria for a moderate severity labeling issue.
Plain-English summary
Abiomed, Inc. is recalling 20 units of the Impella 5.5 Set AU (Product Code: 1000361) due to a potential device interaction with the Shockwave Coronary IVL Catheter during coronary interventions. The recall is being conducted because the current Abiomed labeling, including the Instructions for Use (IFU), does not contain information regarding this specific interaction.
The affected units were distributed worldwide, including in the United States and numerous international markets such as Australia, Canada, and the United Kingdom. Abiomed will update the IFU to include information on this potential device interaction.
Healthcare providers and facilities should check their inventory for the specific serial and batch numbers listed in the recall notice. Users should contact Abiomed for further instructions on how to proceed with the recall and updated labeling.
The recalled product
- Product
- Impella 5.5 Set AU; Product Code: 1000361;
- Manufacturer
- Abiomed, Inc.
- Category
- Medical Device — Cardiovascular
- Affected units
- 20
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: 1000361
- UDI-DI: 00813502012927
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.
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