Boston Scientific Recalls Capio RP Sutures Due to Breakage Risk
Boston Scientific is recalling 2,567 units of Capio RP 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 (breakage/detachment) where no specific injuries or illnesses have been 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 2,567 units of Capio RP sutures, Model #M0068321010. These medical devices are intended for general suturing applications during open surgery to assist in placing suture material in tissues.
The recall was initiated because the sutures have the potential to break and/or detach. The affected products were distributed worldwide to numerous countries, including the United States, Brazil, Canada, and the United Kingdom.
Healthcare providers and patients should stop using these specific sutures. The recall involves specific batch numbers and UDI 08714729470212. Users should contact Boston Scientific for further instructions on how to return or dispose of the affected devices.
The recalled product
- Product
- Capio RP; Model #M0068321010. 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
- 2,567
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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