Z-0879-2021 Class I Terminated
FDA device recall Z-0879-2021 was initiated by Boston Scientific Corporation on November 13, 2020 and is designated Class I. Reason for recall: There is potential for fractures which results in the inability to delivery therapy. The recall status is terminated (terminated July 23, 2024). Affected quantity: 47000 units.
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.