Emblem S-icd Subcutaneous Electrode (2021-09-28)

Recall Summary Boston Scientific's Emblem S-ICD subcutaneous electrode has been recalled across Canada because it may not reliably detect heart rhythms due to a potential manufacturing defect. This device is used in implantable cardioverter defibrillators, which are used to treat patients with abnormal heart rhythms. The recall affects patients who have had this electrode implanted as part of their S-ICD system.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2021-10-15

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/45c5f05e-45d8-43b9-b5d2-160b9fff3588