Medtronic Micra MC1VR01, REF MC1VR01 (OUS only). Cardiac pacemaker.
FDA device recall Z-2493-2019 · posted 2019-09-09 · Terminated
Recall details
- Recalling firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- PNJ
- Quantity affected
- 22244 units
- Distribution
- Worldwide
- Date initiated
- 2019-08-06
- Date posted
- 2019-09-09
- Date terminated
- 2023-06-26
- Location
- Mounds View, MN
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