Recall Z-2492-2019— Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class II · Terminated
Class II FDA medical device recall by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), initiated 2019-08-06, terminated 2023-06-26. FDA's recall record names no specific 510(k) clearance for this event. Product: Medtronic Micra MC1VR01, Single chamber transcatheter pacing system, REF MC1VR01US (US only). Cardiac pacemaker.. 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..
- Recalling firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-08-06
- Terminated
- 2023-06-26
- Firm location
- Mounds View, MN, United States
Product description
Medtronic Micra MC1VR01, Single chamber transcatheter pacing system, REF MC1VR01US (US only). Cardiac pacemaker.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.