The Recall Desk
ModerateFDA (Devices)·Z-2969-2024·Announced 2024-09-11

Impella CP Smart Assist Set: Potential Device Interaction with Coronary Catheter

Abiomed is updating labeling for the Impella CP Smart Assist Set to address a potential device interaction with the Shockwave Coronary IVL Catheter during coronary procedures.

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: FDA Class II device recall with no reported injuries or hospitalizations. The recall addresses a labeling gap regarding a potential device interaction; no adverse events have been reported. This fits the criteria for minor labeling errors without known patient harm.

Plain-English summary

Abiomed, Inc. is recalling the Impella CP Smart Assist Set (Product Code: 1000402) due to a potential device interaction with the Shockwave Coronary IVL Catheter during coronary interventions. 39 units of the affected product have been distributed worldwide, including throughout the United States and numerous international markets.

The Impella CP Smart Assist Set labeling currently does not contain information about the potential interaction between these two devices when used together in coronary intervention procedures.

Abiomed will update the device Instructions for Use to include information on this potential device interaction.

The recalled product

Product
Impella CP Smart Assist Set; Product Code: 1000402;
Manufacturer
Abiomed, Inc.
Category
Medical Device — Cardiac Assist Device
Hazard
  • device-interaction

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: 1000402
  • UDI-DI: 00813502012873

Distribution

Distributed nationwide across the United States.

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