Z-2442-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- August 30, 2023
- Initiation Date
- July 11, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 41,411 units
Product Description
EMBLEM MRI S-ICD Pulse Generator Model A219; Subcutaneous Implantable Cardioverter Defibrillator
Reason for Recall
There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, which may cause S-ICD sensing disablement for a 24-hour interval.
Distribution Pattern
Worldwide
Code Information
GTIN: 00802526581519, 00802526584404, 00802526584411, 00802526590405, 00802526590429, 00802526590436; All EMBLEM S-ICDs enrolled in LATITUDE