Micra MC1VR01 (2019-08-06)
- Starting date:
- August 6, 2019
- Posting date:
- August 23, 2019
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-70791
Last updated: 2019-08-23
Affected Products
Micra MC1VR01
Reason
Medtronic has identified that flushing the delivery system after the tether has been cut may cause the free end of the tether to enter the ventricular chamber and tangle. If this happens, the tangle could potentially prevent tether removal from the delivery system and potentially prevent release of the Micra pacemaker. Therefore, medtronic is updating the IFU and implant procedure tip card to include the recommendation below:
- once the tether is cut, do not flush the delivery system until the tether has been fully removed.
Affected products
Micra MC1VR01
Lot or serial number
All lots.
Model or catalog number
MC1VR01
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway
Minneapolis
55432
Minnesota
UNITED STATES