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

• Reason
• Affected products

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