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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for device where embolism is explicitly stated as a possible adverse event from misplacement. No illnesses or injuries are reported in the source text. Per the rubric, this is a risk-of-harm product where injury has not yet been reported, warranting a High severity rating.
Plain-English summary
SpaceOAR Vue System (UPN SV-1010 and SV-2101) is a medical device manufactured by Boston Scientific Corporation. The system is used to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer, reducing radiation dose to the anterior rectum.
Embolism is a recognized possible adverse event associated with improper hydrogel placement. Approximately 23,368 units have been distributed worldwide, including nationwide distribution in the United States.
Boston Scientific has issued an updated Instructions for Use (IFU) that provides new procedural instructions, warnings, and precautions. The updates include specific steps to verify correct placement of the hydrogel following implantation and technique recommendations for proper SpaceOAR and SpaceOAR Vue placement.
Healthcare providers and patients should review the updated guidance and ensure proper implantation procedures are followed to prevent the risk of embolism associated with hydrogel misplacement.
The recalled product
- 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.
- Manufacturer
- Boston Scientific Corporation
- Hazard
- Affected units
- 23,368
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UPN SV-1010
- GTIN 00850009803009
- Batch Numbers: 26383209
- 26383210
- 26517604
- 26861584
- 26861585
- 26891612
- 26891613
- 27083784
- 27190242
- 27210560
- 27257801
- 27257802
- 27455966
- 27455967
- 27496959
- 27497140
- 27670956
- 27708041
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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