Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2961-2024·Announced 2024-09-11

Impella 5.5 with SmartAssist Set: Potential Device Interaction During Coronary Interventions

Abiomed is updating labeling for Impella 5.5 with SmartAssist Set due to a potential device interaction with Shockwave Coronary IVL Catheter during coronary interventions. The product labeling currently lacks information about this potential interaction.

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: FDA Class II recall for labeling deficiency regarding a potential device interaction. No injuries or illnesses have been reported. The recall is precautionary, with the manufacturer voluntarily updating product labeling to inform clinicians about the potential interaction.

Plain-English summary

The Impella 5.5 with SmartAssist Set is being recalled due to a potential device interaction with the Shockwave Coronary IVL Catheter when both devices are used during coronary interventions. Abiomed has identified that current product labeling lacks information about this potential interaction, which has prompted a labeling update.

Approximately 1,889 units of the affected product were distributed worldwide, including the United States and numerous countries across Europe, Asia, the Middle East, and the Pacific region.

Healthcare providers and patients should review updated product labeling when it becomes available. Clinicians performing coronary interventions should be aware of this potential interaction when using both the Impella 5.5 with SmartAssist Set and the Shockwave Coronary IVL Catheter in the same procedure.

The recalled product

Product: Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002;
Manufacturer: Abiomed, Inc.
Category: Medical Device — Cardiac Interventional
Hazard: device-interaction
labeling-deficiency
Affected units: 1,889

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: 0550-0002
UDI-DI: 00813502011630

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 →

Same manufacturer · Abiomed, Inc.

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