Health product recall

Medtronic Programmers (CareLink, Encore), Medtronic Micra (2019-01-16)

Starting date:
January 16, 2019
Posting date:
February 8, 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-68990

Affected Products

  1. CareLink Programmer
  2. Micra
  3. CareLink Encore Programmer

Reason

Notification to inform customers of the availability of a software update for Medtronic 2090 CareLink and 29901 Encore Programmers. The update is specific to the programmer software that supports the Micra Transcatheter Pacing System (TPS) device and is released under the application software ID: Model SW022 version 8.1. This software update corrects an error in how the programmer calculates and displays the remaining longevity value during a period of time (up to 2 years) prior to the device reaching its recommended replacement time (RRT). A software update is required to ensure that the correct remaining longevity estimate is displayed at all times during the life of the device. Without the software update, the displayed value during this period may remain static and reflect an over-estimation of the remaining longevity. Once the RRT voltage threshold is reached the correct remaining longevity estimate is once again displayed. The software display error does not reflect any issues with the Micra TPS device battery, its ability to deliver therapy and to function as designed. The observed performance of the Micra TPS remains within published expectations.

Affected products

A. CareLink Programmer

Lot or serial number
  • More than 10 numbers, contact manufacturer.
Model or catalog number
  • 2090
Companies
Manufacturer

Medtronic Inc.

710 Medtronic Parkway

Minneapolis, Minnesota

55432

UNITED STATES

B. Micra

Lot or serial number
  • More than 10 numbers, contact manufacturer.
Model or catalog number
  • MC1VR01
Companies
Manufacturer

Medtronic Inc.

710 Medtronic Parkway

Minneapolis, Minnesota

55432

UNITED STATES

C. CareLink Encore Programmer

Lot or serial number
  • More than 10 numbers, contact manufacturer.
Model or catalog number
  • 29901A
Companies
Manufacturer

Medtronic Inc.

710 Medtronic Parkway

Minneapolis, Minnesota

55432

UNITED STATES