FDA recall Z-0950-2021
Boston Scientific Corporation · Class I · device
Product
EMBLEM S-ICD Model A209
Reason for recall
Electrical overstress may lead to device malfunction.
Distribution
Distribution throughout United States and worldwide. Foreign distribution was made to Canada and other countries.
Key facts
- Status
- Terminated
- Initiation date
- 2020-12-02
- Report date
- 2021-02-17
- Termination date
- 2022-06-23
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Saint Paul, MN, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0950-2021