No image published for this recall
Assurity mri pulse generator
Official notice
2 Aug 2022
Last checked
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 VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.
Recall Numbers
Checked manually this time?
The app watches your VIN and alerts you automatically next time — no searching, no checking back.
Turn on automatic VIN checksAffected products
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 vehicles were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand
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.
View full official noticeRelated recalls
Merlin™ 3650 patient care system (pcs)
22 May 2026Assurity and endurity pacemakers
Merlin pcs 3330 software upgrade kit
Neutrino nxt implantable cardioverter defibrilator (icds) and cardiac resynchronization therapy defibrillator (crt-ds)
Merlin patient care system - programmer software
Merlin patient care system - programmer software
Heartsine® samaritan® pad sam 350p sam 360p sam 500p - membrane tail
Hotline IV fluid warmer system & accessories
Intramedullary bone saw blade assembly
Abiomed introducer kits with impella heart pumps
Importation of chinese-authorized ifosfamide for injection due to the current shortage of canadian-authorized ifex (ifosfamide for injection)
Penumbra system red 68 reperfusion catheter
Neutrino nxt implantable cardioverter defibrilator (icds) and cardiac resynchronization therapy defibrillator (crt-ds)
Heartsine® samaritan® pad sam 350p sam 360p sam 500p - membrane tail
Weekly recall digest
Get next week's recalls before you need them.
One email every Monday — official-source recalls for your country, and nothing else. Unsubscribe from any email.
The digest is the slow lane — one email a week. For instant, severity-gated alerts the moment a notice is published, get the app.
This recall was published 2 Aug 2022. The next one won't wait for you to search.
RecallScope watches official sources for the brands and VINs you follow, and alerts you the moment a new notice is published.
