Recalls / —
—#188523
Product
TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE)
- FDA product code
- NAW — Microspheres Radionuclide
- Device class
- Class 3
- Medical specialty
- Unknown
- PMA numbers
- P200029
- Affected lot / code info
- GTIN 05060116920635, Lot Numbers: 61673698, 61673699, 61673700, 61673702, 61694124, 61705932, 61706656, 61705933, 61732176
Why it was recalled
Potential for leaks and loosening at the patient catheter connection
Root cause (FDA determination)
Component change control
Action the firm took
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.
Recalling firm
- Firm
- Boston Scientific Corporation
- Address
- 1 Scimed Pl, Maple Grove, Minnesota 55311-1565
Distribution
- 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.
Timeline
- Recall initiated
- 2021-07-23
- Posted by FDA
- 2021-08-19
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #188523. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.