Boston Scientific Recalls Capio SLIM Suture Capturing Device Due to Breakage Risk
Boston Scientific is recalling 21,250 units of the Capio SLIM Suture Capturing Device because the sutures may break or detach during surgery.
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 is classified as FDA Class II. The hazard involves a medical device defect (suture breakage/detachment) during surgery, which poses a risk of harm, but the source text does not report specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Boston Scientific Corporation is recalling 21,250 units of the Capio SLIM Suture Capturing Device, Model #M0068318250. The device is intended for use in general suturing applications during open surgery to assist in the placement of suture material in tissues at the operative site.
The recall was initiated due to a potential for the Capio sutures to break and/or detach. This defect could compromise the integrity of the surgical closure.
The affected devices were distributed worldwide, including in the United States, Brazil, Guatemala, Ecuador, Malaysia, and numerous other countries. Healthcare providers and facilities that have used or may have used these devices should stop using them and contact Boston Scientific for further instructions.
The recalled product
- Product
- Capio SLIM Suture Capturing Device, Model #M0068318250. Intended for use in general suturing applications during open surgery to assist in the placement of suture material in tissues at the operative site.
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 21,250
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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