Health product recall

Assurity & Endurity Pulse Generarators (Pacemaker) (2021-03-15)

Starting date:
March 15, 2021
Posting date:
April 1, 2021
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-75293

Last updated: 2021-04-01

Affected Products 

  1. ENDURITY PULSE GENERATOR
  2. ASSURITY PULSE GENERATOR
  3. ASSURITY + PULSE GENERATOR
  4. ASSURITY MRI PULSE GENERATOR
  5. ENDURITY MRI PULSE GENERATOR

Reason

Electrical malfunction has been detected at a low rate amongst a subset of Assurity and Endurity Pacemakers manufactured on specific manufacturing equipment between 2015 and 2018. Complaint investigation identified the issue and determined that the electrical issues were due to moisture ingress at the device header caused by incomplete mixing of epoxy during manufacturing.

Affected products

A. ENDURITY PULSE GENERATOR

Lot or serial number
  • Not applicable. 
Model or catalog number
  • PM1160
  • PM2160
Companies
Manufacturer
St. Jude Medical, Cardiac Rhythm Management Division
15900 VALLEY VIEW COURT
Sylmar
91342
California
UNITED STATES

B. ASSURITY PULSE GENERATOR

Lot or serial number
  • Not applicable.
Model or catalog number
  • PM1240
  • PM2240
Companies
Manufacturer
St. Jude Medical, Cardiac Rhythm Management Division
15900 VALLEY VIEW COURT
Sylmar
91342
California
UNITED STATES

C. ASSURITY + PULSE GENERATOR

Lot or serial number
  • Not applicable.
Model or catalog number
  • PM2260
Companies
Manufacturer
St. Jude Medical, Cardiac Rhythm Management Division
15900 VALLEY VIEW COURT
Sylmar
91342
California
UNITED STATES

D. ASSURITY MRI PULSE GENERATOR

Lot or serial number
  • Not applicable.
Model or catalog number
  • PM1272
  • PM2272
Companies
Manufacturer
St. Jude Medical, Cardiac Rhythm Management Division
15900 VALLEY VIEW COURT
Sylmar
91342
California
UNITED STATES

E. ENDURITY MRI PULSE GENERATOR

Lot or serial number
  • Not applicable.
Model or catalog number
  • PM1172
  • PM2172
Companies
Manufacturer
St. Jude Medical, Cardiac Rhythm Management Division
15900 VALLEY VIEW COURT
Sylmar
91342
California
UNITED STATES

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