FDASeptember 1, 2015device

Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performing cardiac ablation procedures.

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

The hazard

An issue with a USB memory component contained within a subset of CryoConsoles can result in extended procedure time.

What to do

FDA enforcement status: Terminated

Brands named

medtronic inc cardiac rhythm disease managementmedtronicmedtronic inc

Recall history

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

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