Boston Scientific Recalls Capio Open Access Box 4 Sutures
Boston Scientific is recalling 21,051 units of Capio Open Access Box 4 sutures due to a potential for the sutures to break or detach during use.
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, and the hazard involves a risk of harm (suture breakage/detachment) in a medical device where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Boston Scientific Corporation is recalling 21,051 units of the Capio Open Access Box 4 (Capio OPC), Model #M0068311251. These medical devices are intended for use in general suturing applications during open or endoscopic surgery to assist in the placement of suture material in tissues at the operative site.
The recall was initiated because of a potential for the Capio sutures to break and/or detach. The affected units were distributed worldwide, including in the United States and numerous other countries such as Brazil, Canada, Germany, and Japan.
Healthcare providers and facilities that have received these devices should stop using them and contact Boston Scientific Corporation for further instructions on how to return or dispose of the product. Patients who have had surgery using these specific devices should consult their healthcare provider if they have concerns about their surgical site.
The recalled product
- Product
- Capio Open Access Box 4 (Capio OPC); Model #M0068311251. Intended for use in general suturing applications during open or endoscopic surgery to assist in the placement of suture material in tissues at the operative site.
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 21,051
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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