Recall Z-1002-2022 ยท OVB Hydrogel Spacer
Boston Scientific Corporation
SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101. 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.
| Date | Feb 24, 2022 |
| Status | Open, Classified |
| Reason | Users need to be aware that embolism is a possible adverse event associated with hydrogel misplacements. Updated IFU provides new procedural instructions, warnings and precautions that describe steps to verify correct placement of the hydrogel following implantation, as well as technique recommendations for the proper placement of SpaceOAR and SpaceOAR Vue. |
| Root cause | Labeling design |
| Action | An URGENT MEDICAL DEVICE PRODUCT ADVISORY dated 2/24/22 was sent to customers. Inadvertent placement of SpaceOAR gel into a blood vessel and subsequent migration of the hydrogel outside of the pelvis, led to embolism. Boston Scientific will incorporate best practices regarding hydrogel placement during all SpaceOAR procedures into the IFU. The updated IFUs will be packaged with SpaceOAR and SpaceOAR Vue Systems after regulatory approvals are obtained for the IFU updates. This Product Advisory contains the recommended IFU updates, located in Appendix 1, intended to: -Raise awareness of em |
| Quantity | 61,852 units |
| Distribution | Worldwide - US Nationwide distribution. |
| FDA record | Open on fda.gov |