FDA-Device2019-09-18Class II
Medtronic Micra MC1VR01, Single chamber transcatheter pacing system, REF MC1VR01US (US only). Cardiac pacemaker.
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
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.
Sold states
Worldwide
Affected count
24521 units
Manufactured in
8200 Coral Sea St Ne, Mounds View, MN, United States
Products
Medtronic Micra MC1VR01, Single chamber transcatheter pacing system, REF MC1VR01US (US only). Cardiac pacemaker.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2492-2019Don't want to check this manually?
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