Abiomed Impella Pump Recall for Potential Shockwave Catheter Interaction
Abiomed is recalling 43,636 Impella Pumps to update instructions for use 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 but involves a labeling update for a potential interaction without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Abiomed, Inc. is recalling 43,636 units of the Pump 371 14F LT CMR Set (Product Code: 0048-0045) due to a potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. The recall is classified as Class II by the FDA.
The recall is initiated because Abiomed currently lacks labeling content, such as Instructions for Use (IFU), that addresses this specific potential interaction. As a corrective action, 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. Healthcare providers and consumers should check their device serial numbers against the provided list and contact Abiomed for updated labeling information.
The recalled product
- Product
- Pump 371 14F LT CMR Set; Product Code: 0048-0045;
- Manufacturer
- Abiomed, Inc.
- Category
- Medical Device — Cardiovascular
- Affected units
- 43,636
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: 0048-0045
- UDI-DI: 00813502011876
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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