FDA-Device2020-12-30Class II
Five IceSphere" Prostate Cryoablation Kit
Hazard
Complaint trend regarding needle shaft gas leaks.
Sold states
Nationwide
Affected count
419 units
Manufactured in
1 Scimed Pl, N/A, Maple Grove, MN, United States
Products
Five IceSphere" Prostate Cryoablation Kit
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0689-2021More Boston Scientific Corporation recalls
- FDA-Device2026-07-22Boston Scientific Rapid Refill Continuous Injection System recalled for syringe disconnection risk
- FDA-Device2026-07-08Boston Scientific CRE Pro Wireguided catheters recalled for potential sterile pouch breach
- FDA-Device2026-07-08Boston Scientific CRE Pro Wireguided catheters recalled for sterile pouch breach risk
- FDA-Device2026-07-08Boston Scientific CRE Pro Wireguided catheters recalled for potential sterile pouch breach
- FDA-Device2026-07-08Boston Scientific CRE Pro Wireguided catheters recalled for potential sterile packaging breach
Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief