Recall Z-2327-2021 ยท NAW Microspheres Radionuclide
Boston Scientific Corporation
TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE)
| Date | Aug 19, 2021 (initiated Jul 23, 2021) |
| Status | Open, Classified |
| Reason | Potential for leaks and loosening at the patient catheter connection |
| Root cause | Component change control |
| Action | 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. |
| Quantity | 4980 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, Portugal, Saudi Arabia, Singapore, Switzerland, Turkey, and Argentina. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.