Impella 5.5 Cardiac Pump Recalled for Undocumented Device Interaction
Abiomed recalled 413 units of Impella 5.5 with SmartAssist S2 pumps worldwide due to a potential undocumented interaction with Shockwave coronary catheters during cardiac procedures. The company will update product labeling to disclose this interaction.
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: This Class II recall addresses a labeling deficiency for a potential device interaction that has not been associated with reported illnesses or injuries. Per the rubric, precautionary recalls without documented adverse events are classified as Moderate (2) in severity.
Plain-English summary
Abiomed, Inc. is recalling 413 units of the Impella 5.5 with SmartAssist S2 Set (Product Code 1000482) due to a potential device interaction that was not previously documented in product labeling.
The issue involves a potential interaction between the Impella 5.5 left-sided cardiac pump and the Shockwave Coronary IVL Catheter when used together during coronary interventions. While no reported illnesses or injuries have been associated with this interaction, Abiomed identified the need to document this potential risk in the product's Instructions for Use (IFU) and labeling materials.
The recalled devices were distributed worldwide, including throughout the United States and to 38 countries including Australia, Canada, Germany, Japan, and the United Kingdom.
Affected parties should consult the updated labeling when provided by Abiomed and follow those instructions regarding use of these devices together during coronary procedures.
The recalled product
- Product
- Impella 5.5 with SmartAssist S2 Set, EU; Product Code: 1000482;
- Manufacturer
- Abiomed, Inc.
- Affected units
- 413
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: 1000482
- UDI-DI: 00813502013276
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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