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TheraSphere Y90 Glass Microspheres 17.5 GBq (US Commercial)
BIOCOMPATIBLES UK LTD · Model OTT-SPE-FP-700 (990700.SPE) · UDI-DI 05060116921663
NAW
Prescription
0
510(k) clearances
578
Adverse events (142 deaths)
5
Recalls
8
Facilities
Description
TheraSphere Yttrium-90 Glass Microspheres 17.5 GBq Dose (US Commercial)
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 and the actual does wa |
| 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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.