EMBLEM S-ICD SUBCUTANEOUS ELECTRODE (2021-09-28)

Starting date:

September 28, 2021

Posting date:

October 15, 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-76647

Last updated: 2021-10-15

• Reason
• Affected products

Affected Products

EMBLEM S-ICD SUBCUTANEOUS ELECTRODE

Reason

In December 2020, Boston Scientific notified users of the Emblem Electrode (Model 3501) about the potential for body fractures distal to the proximal sense ring. The electrode demonstrated a low malfunction rate and has continued to be available while a design enhancement was pursued. Facilities are requested to return the affected/original electrodes as the enhanced version is now available.

Affected products