Recall Z-2493-2019 ยท PNJ Leadless Pacemaker
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medtronic Micra MC1VR01, REF MC1VR01 (OUS only). Cardiac pacemaker.
| Date | Sep 9, 2019 (initiated Aug 6, 2019) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | In the US, beginning 06-Aug-2019, Medtronic Field Representatives are approved to provide the Instructions for Use Update Letter to physicians who have been trained to implant the Micra device as identified by Medtronic training records. Courtesy notifications to Risk Managers at accounts that have purchased Micra and Clinical Principal Investigators (PIs) at sites participating in clinical trials are also approved to be provided. The Instructions for Use Update letter will be sent via 2-day delivery beginning 12-Aug-2019 to the physicians and risk managers. |
| Quantity | 22244 units |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.