Boston Scientific Recalls Capio Sutures Due to Breakage Risk
Boston Scientific is recalling 4,144 units of Capio Standard Box 4 sutures because they 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 involves a medical device with a risk of harm (suture breakage/detachment) where no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Boston Scientific Corporation is recalling 4,144 units of Capio Standard Box 4 (Capio PC) sutures, Model #M0068312321. These devices are intended for general suturing applications during open or endoscopic surgery to assist in the placement of suture material in tissues at the operative site.
The recall is being issued because of the potential for the sutures to break and/or detach. The affected units were distributed worldwide, including in the United States and numerous international markets.
Healthcare facilities and consumers should stop using the affected sutures and contact Boston Scientific for further instructions.
The recalled product
- Product
- Capio Standard Box 4 (Capio PC); Model #M0068312321. 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
- 4,144
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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