Home › Device types › NAW
Microspheres Radionuclide
FDA product code NAW · Class 3 · Unknown
113
Registered devices
583
Adverse events
5
Recalls
0
510(k) clearances
Devices with this code
TheraSphere™ — BOSTON SCIENTIFIC CORPORATIONTheraSphere Y90 Glass Microspheres 7.5 GBq — BIOCOMPATIBLES UK LTDTheraSphere Y90 Glass Microspheres 16.5 GBq — BIOCOMPATIBLES UK LTDTheraSphere Y90 Glass Microspheres 10 GBq — BIOCOMPATIBLES UK LTDTheraSphere™ — BOSTON SCIENTIFIC CORPORATIONTheraSphere Y90 Glass Microspheres 19.5 GBq (US Commercial) — BIOCOMPATIBLES UK LTDTheraSphere Y90 Glass Microspheres 18.5 GBq (US Commercial) — BIOCOMPATIBLES UK LTDTheraSphere Y90 Glass Microspheres 19.0 GBq (US Commercial) — BIOCOMPATIBLES UK LTDTheraSphere Y90 Glass Microspheres 13.5 GBq — BIOCOMPATIBLES UK LTDTheraSphere Y90 Glass Microspheres 15.5 GBq — BIOCOMPATIBLES UK LTDTheraSphere Y90 Glass Microspheres 5.0 GBq (US Commercial) — BIOCOMPATIBLES UK LTDTheraSphere™ — BOSTON SCIENTIFIC CORPORATIONTheraSphere Y90 Glass Microspheres 10.5 GBq (US Commercial) — BIOCOMPATIBLES UK LTDTheraSphere Y90 Glass Microspheres 7 GBq — BIOCOMPATIBLES UK LTDTheraSphere Y90 Glass Microspheres 3 GBq — BIOCOMPATIBLES UK LTDTheraSphere Y90 Glass Microspheres 5.5 GBq — BIOCOMPATIBLES UK LTDTheraSphere Y90 Glass Microspheres 9.5 GBq — BIOCOMPATIBLES UK LTDTheraSphere™ — BOSTON SCIENTIFIC CORPORATIONTheraSphere Y90 Glass Microspheres 5 GBq — BIOCOMPATIBLES UK LTDTheraSphere Y90 Glass Microspheres 8.0 GBq — BIOCOMPATIBLES UK LTDTheraSphere Y90 Glass Microspheres 16.0 GBq (US Commercial) — BIOCOMPATIBLES UK LTDTheraSphere Y90 Glass Microspheres 12.0 GBq (US Commercial) — BIOCOMPATIBLES UK LTDTheraSphere Y90 Glass Microspheres 8.0 GBq (US Commercial) — BIOCOMPATIBLES UK LTDTheraSphere Y90 Glass Microspheres 6.0 GBq — BIOCOMPATIBLES UK LTD
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-07-23 | Boston Scientific Corporation | Potential for leaks and loosening at the patient catheter connection |
| 2021-07-23 | Boston Scientific Corporation | Potential for leaks and loosening at the patient catheter connection |
| 2015-09-21 | Biocompatibles U.K., Ltd. | One mislabeled dose of TheraSphere Y-90 Glass Microspheres, which was shipped to Hong Kong (total radioactivity incorrect). The product ws labeled as 10 GBq an |
| 2013-02-27 | Sirtex Medical Limited | Incorrect expiration date |
| 2009-02-24 | MDS Canada Inc. DBA MDS Nordion | Instructions for the use of the pinch clamp that is an integral part of the TheraSphere Administration Set were not included with the distribution of the device |
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