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Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Medtronic Micra MC1VR01, REF MC1VR01 (OUS only). Cardiac pacemaker.
Recalled September 18, 2019 · FDA recall Z-2493-2019 · 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. · FDA Class II
Units
22244 units
Sold at
Worldwide
Description
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.
Product
Medtronic Micra MC1VR01, REF MC1VR01 (OUS only). Cardiac pacemaker.
Manufacturer(s)
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →