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FDAAugust 5, 2024device

Impella 5.5 with SmartAssist Set, US; Product Code: 0550-0008;

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.

What to do

FDA enforcement status: Ongoing

Brands named

abiomed

UPCs

00813502011531

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Impella 5.5 with SmartAssist Set, US; Product Code: 0550-0008; — Recall Details · AllClear