Z-0879-2021 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 27, 2021
- Initiation Date
- November 13, 2020
- Termination Date
- July 23, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 47000 units
Product Description
EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardioverter defibrillator (ICD)
Reason for Recall
There is potential for fractures which results in the inability to delivery therapy.
Distribution Pattern
Worldwide distribution including US and US territories, Canada, Latin America, Europe, Middle East, Africa, and Asia-Pacific region
Code Information
All serialized EMBLEM Subcutaneous Electrodes Model 3501 manufactured and distributed are subject to this worldwide advisory communication.