Boston Scientific SpaceOAR System Embolism Risk from Hydrogel Misplacement
FDA recalls Boston Scientific's SpaceOAR System due to risk of embolism from incorrect hydrogel placement during prostate cancer radiotherapy. Updated instructions provide verification steps for proper placement.
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: This FDA Class II recall involves a serious risk of embolism from device misplacement. While no injuries are reported in the source material, embolism is a potentially life-threatening condition, qualifying this as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
The SpaceOAR System is a medical device used during radiotherapy for prostate cancer to temporarily position the anterior rectal wall away from the prostate, reducing the radiation dose delivered to the rectum. Boston Scientific Corporation is recalling this product due to the risk of embolism (a potentially serious blood clot condition) associated with improper placement of the hydrogel component.
Approximately 61,852 units of the SpaceOAR System have been distributed worldwide, including throughout the United States. The recall affects multiple product variants (UPN SO-1010, SO-2101, SO-3101, and SO-4101) across numerous batch numbers.
To mitigate this risk, Boston Scientific has issued updated instructions for use that include new procedural instructions, warnings, and precautions. These materials provide specific steps to verify correct placement of the hydrogel following implantation and offer technique recommendations for proper device positioning of the SpaceOAR and SpaceOAR Vue systems.
The recalled product
- Product
- 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.
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 61,852
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 SO-1010
- GTIN 00864661000157
- Batch Numbers: 25512955
- 25512956
- 25608548
- 25646105
- 25652246
- 25676663
- 25676664
- 25681783
- 25814685
- 25814686
- 25814687
- 25822800
- 25822812
- 25822814
- 25822815
- 25822818
- 25846481
- 26059500
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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