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Boston Scientific Corporation recalls TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE)
Recalled August 25, 2021 · FDA recall Z-2327-2021 · Boston Scientific
Hazard
Potential for leaks and loosening at the patient catheter connection · FDA Class II
Units
4980 sets
Sold at
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.
Description
Potential for leaks and loosening at the patient catheter connection
Product
TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE)
Manufacturer(s)
Boston Scientific Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →