FDAAugust 6, 2019device
Medtronic Micra MC1VR01, Single chamber transcatheter pacing system, REF MC1VR01US (US 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
00643169529748
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- CPSCMissry Associates Recalls Misco Sports Badminton Toy Sets Due to Risk of Serious Injury or Death from Battery Ingestion; Violates Mandatory Standard for Toys2026-05-14
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