FDA-Device2021-08-25Class II
TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE)
Hazard
Potential for leaks and loosening at the patient catheter connection
Sold states
Worldwide distribution - US Nationwide and the countries of Belgium, Canada, Germany, Spain, France, United Kingdom/Great Britain, Hong Kong, Ireland, Israel, India, Italy, Netherlands, Poland, Portugal, Saudi Arabia, Singapore, Switzerland, Turkey, and Argentina.
Affected count
4200 sets
Manufactured in
1 Scimed Pl, N/A, Maple Grove, MN, United States
Products
TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2328-2021More Boston Scientific Corporation recalls
- 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
- FDA-Device2026-07-08CRE Wireguided 8-10mm 240cm
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