Health product recall

EMBLEM S-ICD SUBCUTANEOUS ELECTRODE (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-74559

Last updated:
2020-12-18

Affected Products

EMBLEM S-ICD SUBCUTANEOUS ELECTRODE

Reason

Potential for electrode body fracture. To date 27 reports received.

Affected products

EMBLEM S-ICD SUBCUTANEOUS ELECTRODE

Lot or serial number

Not applicable.

Model or catalog number

3501

Companies
Manufacturer

Boston Scientific Corporation

4100 Hamline Avenue North

St. Paul

55112-5798

Minnesota

UNITED STATES