Health product recall

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-74561

Last updated:
2020-12-18

Affected Products

A. EMBLEM S-ICD PULSE GENERATOR

B. EMBLEM MRI S-ICD PG

Reason

Low voltage capacitor causing accelerated battery depletion.

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

60A219899, 60A219803

Model or catalog number

A219

Companies
Manufacturer

Boston Scientific Corporation

4100 Hamline Avenue North

St. Paul

55112-5798

Minnesota

UNITED STATES