FDAAugust 6, 2019device

Medtronic Micra MC1VR01, REF MC1VR01 (OUS only). Cardiac pacemaker.

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

The hazard

Medtronic is updating the Micra Instructions for Use (IFU) and the Micra Implant Procedure Tip Card to include specific information on the removal of the tether to release the Micra Pacemaker from the Micra Delivery System during implant.

What to do

FDA enforcement status: Terminated

Brands named

medtronic inc cardiac rhythm and heart failure crhfmedtronicmedtronic inc

UPCs

00643169529731

Recall history

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

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Medtronic Micra MC1VR01, REF MC1VR01 (OUS only). Cardiac pacemaker. — Recall Details · AllClear