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Assurity mri pulse generator
Official notice
2 Aug 2022
An official Health Canada notice concerns Assurity mri pulse generator. 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 Published 2022-08-02.
What to do now
Contact the manufacturer if you require additional information.
Recall number
64427
Official notice
2022-08-02
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
Recall Numbers
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Affected products
Product 1
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Manufacturer
Phone
Brand: St Jude Medical Cardiac Rhythm Management Division, Assurity Mri Pulse Generator.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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