Boston Scientific Recalls Uphold Vaginal Support System Due to Suture Breakage
Boston Scientific is recalling 1,002 Uphold Vaginal Support Systems because the Capio sutures may break or detach.
What this means for you
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: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Boston Scientific Corporation is recalling 1,002 units of the Uphold Vaginal Support System, Model #M0068317080. This medical device is indicated for tissue reinforcement in women with pelvic organ prolapse.
The recall was initiated due to a potential for the Capio sutures to break and/or detach. The affected units are identified by GTIN 08714729773955 and specific batch numbers including ML00002892, ML00003166, ML00003060, ML00003291, ML00003119, ML00003435, and ML00003516.
The affected products were distributed worldwide to numerous countries, including the United States, Brazil, Canada, and the United Kingdom. Patients who have received this device should contact their healthcare provider for evaluation and appropriate management.
The recalled product
- Product
- Uphold Vaginal Support System; Model #M0068317080. Indicated for tissue reinforcement in women with pelvic organ prolapse.
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Gynecological
- Affected units
- 1,002
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 11 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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