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SIR-Spheres Y-90 resin microspheres

Sirtex Medical Inc. · Model SIR-Y001 · UDI-DI 00850014612030

NAW Prescription

510(k) clearances

583

Adverse events (142 deaths)

Recalls

Facilities

Description

SIR-Y001 (3Gbq/5ml): SIR-Spheres Y-90 resin microspheres consist of biocompatible resin microspheres containing yttrium-90 with a size between 20 and 60 microns in diameter. Each vial contains 3 GBq of Y90 ± 10% (at the time of calibration) in a total of 5 cc water for injection. Yttrium-90 is a high-energy pure beta-emitting isotope with no primary gamma emission. The maximum energy of the beta particles is 2.27MeV with a mean of 0.93MeV. The maximum range of emissions in tissue is 11mm with a mean of 2.5mm. This is a brachytherapy product considered to be a sealed source device. The yttrium-90 has a purity specification of 999,900 ppm at reference, at (or after) time of manufacture of SIR-Spheres microspheres. The half-life is 64.1 hours. In use requiring the isotope to decay to infinity, 94% of the radiation is delivered in 11 days leaving only background radiation with no therapeutic value. SIR-Spheres microspheres themselves are a permanent implant. Each device is for single patient use.

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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Data 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.