Microspheres Radionuclide
FDA product code NAW · Class III (high risk) · Radiology
Approved PMA: P990065
0510(k) clearances
2PMA approvals
5recalls
Implantimplanted device
PMA approvals
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2328-2021 Class II | TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE)Potential for leaks and loosening at the patient catheter connection | Boston Scientific Corporation | 07/23/2021Open, Classified |
| Z-2327-2021 Class II | TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE)Potential for leaks and loosening at the patient catheter connection | Boston Scientific Corporation | 07/23/2021Open, Classified |
| Z-0078-2017 Class II | TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION TheraSphere is indicated for…One mislabeled dose of TheraSphere Y-90 Glass Microspheres, which was shipped to Hong Kong (total… | Biocompatibles U.K., Ltd. | 09/21/2015Terminated |
| Z-1162-2013 Class III | Sirtex SIR-yttrium 90 microspheres (Radionuclide); SIR-Y001. Indicated for the treatment…Incorrect expiration date | Sirtex Medical Limited | 02/27/2013Terminated |
| Z-1325-2009 | TheraSphere Administration Set (Part Number K125914-034). TheraSphere is indicated for…Instructions for the use of the pinch clamp that is an integral part of the TheraSphere Administration Set… | MDS Canada Inc. DBA MDS Nordion | 02/24/2009Terminated |