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
- ENDURITY PULSE GENERATOR
- ASSURITY PULSE GENERATOR
- ASSURITY + PULSE GENERATOR
- ASSURITY MRI PULSE GENERATOR
- 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