SpaceOAR Vue System Recalled for Embolism Risk from Misplacement
The SpaceOAR Vue System implant used in prostate cancer radiotherapy is being recalled because improper hydrogel placement can cause embolism. Boston Scientific has updated instructions and warnings to prevent misplacement.
- Product
- SpaceOAR Vue System, UPN SV-1010 and SV-2101. Used to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer to reduce the radiation dose delivered to the anterior rectum.
- Category
- Medical Device
- Distribution
- Distributed nationwide