Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Medtronic Micra MC1VR01, REF MC1VR01 (OUS only). Cardiac pacemaker.
- Recall date
- August 6, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2493-2019
- FDA classification
- Class II
- Brand / firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Sold / distributed
- Worldwide
Why it was recalled
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Medtronic Micra MC1VR01, REF MC1VR01 (OUS only). Cardiac pacemaker.
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