Health product recall

Assurity Mri Pulse Generator

Last updated

Summary

Product
Assurity Mri Pulse Generator
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalogue number
Assurity Mri Pulse Generator More than 10 numbers, contact manufacturer. PM2272

Issue

Abbott has identified that a subset of Assurity and/or Endurity pacemaker(s) are impacted by a manufacturing issue.  As background, the issue in this recall is connected to a manufacturing laser roughening process, unique to a single assembly site production line, which may not have properly prepared the device's metal housing potentially leading to an abnormal bond adhesion. This in turn may allow moisture ingress into the pulse generator header. This specific manufacturing process is no longer in use.  While Abbott continues to investigate this issue further, Abbott has initiated a recall of the impacted devices, which will be executed in two phases: phase I initiated now and phase II initiated on July 28,2022.  Endurity pacemaker(s) PM2172 not distributed  in Canada.

Recall start date: July 20, 2022

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies

St. Jude Medical, Cardiac Rhythm Management Division

15900 Valley View Court, Sylmar, California, United States, 91342

Published by
Health Canada
Audience
Healthcare
Recall class
Type I
Identification number
RA-64427

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