This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
Micra MC1VR01
- Starting date:
- January 26, 2017
- Posting date:
- February 14, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-62192
Reason
Manufacturer is notifying customers regarding an update for Micra Transcatheter Pacing System Devices which corrects an RPO firmware anomaly and revises nominal sensing settings. Incorrect rate profile optimization (RPO) parameters may result in aggressive pacing therapy.
Affected products
Micra MC1VR01
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
MC1VR01
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway NE
Minneapolis
55432
Minnesota
UNITED STATES