Device product

TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE)

Z-2328-2021

July 23, 2021

Class II

Product summary

Firm: Boston Scientific Corporation
Event: Event 88369
Status: Ongoing
Classification: Class II
Quantity: 4200 sets
Official record key: device-enforcement:Z-2328-2021

Official wording

Reason: Potential for leaks and loosening at the patient catheter connection

Code information: GTIN 05060116920635, Lot Numbers: 61673698, 61673699, 61673700, 61673702, 61694124, 61705932, 61706656, 61705933, 61732176

Distribution pattern: 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.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Potential for leaks and loosening at the patient catheter connection