Health product recall

Merlin Patient Care System - Programmer Software

Last updated

Summary

Product
Merlin Patient Care System - Programmer Software
Issue
Medical devices - Software defect
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products

Lot or Serial Number

Model or catalog number

Merlin Patient Care System - Programmer Software

3330 VER 25.0.4, 3330 VER 25.2.4, 3330 VER 25.3.4

3330 VER 25.2.4, 3330 VER 25.0.4, 3330 VER 25.3.4

Issue

Abbott is notifying physicians of a programmer software anomaly that may be encountered in a very specific circumstance when executing a pacing capture decrement test in-clinic on a gallant, neutrino NXT, or entrant device using a merlin patient care system (PCS) programmer. If a user presses the "hold to test" button and decides to stop testing by releasing the button prior to the first voltage decrement (within a narrow time window approximately 2.5 seconds after test initiation), the programmer may continue to execute the decrement test instead of terminating the test and restoring the permanent programmed pacing parameters. Under this scenario, the decrement test will continue running until an output of 0.25V is reached or until telemetry communication is broken. For pacemaker dependent patients, there is a potential for this scenario to cause a transient asystole until permanent parameters are restored if the voltage is below the patient's capture threshold.

Recall start date: Mar 15, 2022

Additional information

Details
Original published date: 2022-03-31
Alert / recall type
Health product recall
Category
Health product - Medical device - Cardiovascular
Companies

St. Jude Medical, Cardiac Rhythm Management Division

15900 Valley View Court, Sylmar, California

United States, 91342

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-64031