Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2971-2024·Announced 2024-09-11

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.

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: 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.
Category: Medical Device — Cardiac Assist Device
Hazard: device-interaction
labeling-deficiency
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.

See all 18 products in this recall →

Same manufacturer · Abiomed, Inc.

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Same hazard · device interaction