TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE)
FDA device recall Z-2328-2021 · posted 2021-08-19 · Open, Classified
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Potential for leaks and loosening at the patient catheter connection
- Action taken
- The firm disseminated a Medical Device Product Advisory on 07/23/2021 by overnight mail delivery. The letter explained the issue and directed users to ensure a firm connection is made between the outlet luer and the patient catheter prior to, and during ThersSphere administration.
- Root cause
- Component change control
- Status
- Open, Classified
- Product code
- NAW
- Quantity affected
- 4200 sets
- Distribution
- 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, Portug
- Date initiated
- 2021-07-23
- Date posted
- 2021-08-19
- Location
- Maple Grove, MN
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