EMBLEM S-ICD PULSE GENERATOR & EMBLEM MRI S-ICD PG (2020-12-03)
- Starting date:
- December 3, 2020
- Posting date:
- December 18, 2020
- 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-74557
Last updated:
2020-12-18
Affected Products
A. EMBLEM S-ICD PULSE GENERATOR
B. EMBLEM MRI S-ICD PG
Reason
Potential for electrical overstress during delivery of high voltage therapy. To date, 6 events have occurred.
Affected products
A. EMBLEM S-ICD PULSE GENERATOR
Lot or serial number
60A209400
60A209600
Model or catalog number
A209
Companies
- Manufacturer
-
Boston Scientific Corporation
4100 Hamline Avenue North
St. Paul
55112-5798
Minnesota
UNITED STATES
B. EMBLEM MRI S-ICD PG
Lot or serial number
60A219800
60A219803
Model or catalog number
A219
Companies
- Manufacturer
-
Boston Scientific Corporation
4100 Hamline Avenue North
St. Paul
55112-5798
Minnesota
UNITED STATES