Boston Scientific Recalls Uphold LITE Pelvic Organ Prolapse Mesh Devices
Boston Scientific is recalling Uphold LITE w/ Capio SLIM devices due to a potential for the Capio sutures to break or detach.
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: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.
Plain-English summary
Boston Scientific Corporation is recalling the Uphold LITE w/ Capio SLIM (Model #M0068318170), a medical device indicated for tissue reinforcement in women with pelvic organ prolapse. The recall involves 24,126 units that were distributed worldwide, including in the United States and numerous other countries.
The recall is being conducted because of a potential for the Capio sutures to break and/or detach. The source text does not report any specific injuries, illnesses, or deaths associated with this defect.
Healthcare providers and patients who have received this device should contact Boston Scientific Corporation for further instructions on how to proceed.
The recalled product
- Product
- Uphold LITE w/ Capio SLIM; Model #M0068318170. Indicated for tissue reinforcement in women with pelvic organ prolapse.
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 24,126
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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