Health product recall

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