Emblem S-icd Pulse Generator & Emblem Mri S-icd Pg (2020-12-03)
Recall Summary Boston Scientific is recalling certain Emblem S-ICD and Emblem MRI S-ICD pulse generators (implantable heart devices) distributed across Canada. The recall was issued due to a potential malfunction in the device's sensing circuitry that could cause it to fail to detect abnormal heart rhythms. Patients who have received these specific pulse generators are affected by this recall.
- Reason
- Medical devices
- Classification
- Class I
- Category
- drug recall
- Country
- Canada
- Agency
- HC-DEVICES
- Recall date
- 2020-12-18
- Status
- Ongoing
- Distribution
- Canada-wide
Official recall notice from HC-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/d6b7cf45-0966-4222-8557-288d32868aa4