FDA recall Z-0686-2021
Boston Scientific Corporation · Class II · device
Product
IceRod" i-Thaw" Prostate Cryoablation Kit
Reason for recall
Complaint trend regarding needle shaft gas leaks.
Distribution
Nationwide
Key facts
- Status
- Completed
- Initiation date
- 2020-11-18
- Report date
- 2020-12-30
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Maple Grove, MN, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0686-2021