Medtronic Micra MC1VR01, REF MC1VR01 (OUS only). Cardiac pacemaker.
Reported: September 18, 2019 Initiated: August 6, 2019 #Z-2493-2019
Product Description
Medtronic Micra MC1VR01, REF MC1VR01 (OUS 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.
Details
- Recalling Firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Units Affected
- 22244 units
- Distribution
- Worldwide
- Location
- Mounds View, MN
Frequently Asked Questions
What product was recalled? ▼
Medtronic Micra MC1VR01, REF MC1VR01 (OUS only). Cardiac pacemaker.. Recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF). Units affected: 22244 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 18, 2019. Severity: Moderate. Recall number: Z-2493-2019.
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