Boston Scientific Recalls Colpassist Vaginal Positioning Device Due to Sterility Risk
Boston Scientific is recalling Colpassist Vaginal Positioning Devices due to potential pinholes that may compromise sterility and cause post-operative infection.
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 post-operative infection due to a sterile barrier breach, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Boston Scientific Corporation is recalling the Colpassist Vaginal Positioning Device (Material No. M0068318210). The device is intended for use in general gynecological surgery to assist in the positioning and manipulation of the vagina during the procedure.
The recall is being issued because of a potential for pinholes on the edge of the pouch, which could breach the sterile barrier. This breach may render the device non-sterile and result in a post-operative infection. The recall affects 4,549 units distributed worldwide, including the United States and numerous international locations.
Healthcare facilities and distributors should stop using the affected devices and contact Boston Scientific for instructions on return or replacement. Patients who have had the device used during surgery should contact their healthcare provider if they experience signs of infection.
The recalled product
- Product
- Colpassist Vaginal Positioning Device - Product Usage: intended for use in general gynecological surgery to assist in the positioning and manipulation of the vagina during the procedure. Material No. M0068318210
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 4,549
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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