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Proclaim 5/7 Elite Implantable Pulse Generator (2017-09-12)
- Starting date:
- September 12, 2017
- Posting date:
- September 26, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Hospitals, Healthcare Professionals
- Identification number:
- RA-64590
Affected products
- PROCLAIM 5 ELITE IMPLANTABLE PULSE GENERATOR
- PROCLAIM 7 ELITE IMPLANTABLE PULSE GENERATOR
Reason
Abbott is advising physicians that our company is aware of instances in which the elective replacement indicator (ERI) in some devices has triggered earlier than intended. In these cases, the ERI alerts were triggered early due to an error in how the device calculates the actual remaining battery life in the impacted implantable pulse generators (IPG).
Affected products
A. PROCLAIM 5 ELITE IMPLANTABLE PULSE GENERATOR
Lot or serial number
Not applicable
Model or catalog number
3660
Companies
- Manufacturer
-
St. Jude Medical
6901 Preston Road
Plano
75024
Texas
UNITED STATES
B. PROCLAIM 7 ELITE IMPLANTABLE PULSE GENERATOR
Lot or serial number
Not applicable
Model or catalog number
3662
Companies
- Manufacturer
-
St. Jude Medical
6901 Preston Road
Plano
75024
Texas
UNITED STATES