Boston Scientific Corporation: Uphold LITE w/ Capio SLIM; Model #M0068318170. Indicated for tissue reinforcement in women with pelvic organ prolapse.

Is my product affected?

Uphold LITE w/ Capio SLIM; Model #M0068318170. Indicated for tissue reinforcement in women with pelvic organ prolapse.

• UPC 08714729839200

Check against the official notice below — it lists the full affected range.

What happened

Boston Scientific Corporation is recalling the Uphold LITE w/ Capio SLIM device (Model #M0068318170), which is used for tissue reinforcement in women with pelvic organ prolapse. The recall affects 24,126 units distributed worldwide across more than 40 countries. The devices are being recalled because the Capio sutures in the product have the potential to break and/or detach.

The recall involves specific batch numbers listed in the recall record. The source document does not specify a remedy or recommended action for consumers who may have received this device.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Potential for Capio sutures to break and /or detach.

Details from the source

Reason for recall: Potential for Capio sutures to break and /or detach. Distribution: Worldwide Distribution -- US, Brazil, Guatemala, Ecuador, Malaysia, Czech Republic, United Kingdom, Argentina, Honduras, Peru, Singapore, Denmark, Iceland, Chile, Nicaragua, Venezuela, Japan, Egypt, Israel, Canada, Panama, Taiwan, United Arab Emirates, Finland, Ireland, Mexico, Dominican Republic, Hong Kong, Austria, France, Italy, Costa Rica, Trinidad and Tobago, Australia, Bahrain, Georgia, Isla Quantity: 24,126 Lot/code info: UDI:08714729839200 Batch numbers: 27019 56827 21250249 27898 56829 21271669 28713 57715 21336724 28974 57716 21377535 29299 58081 21402115 30503 58083 21432026 31359 58944 21447170 31516 58945 21496403 32828 60407 ML00002769 32829 60409 ML00002810 33791 61098 ML00002857 33792 61420 ML00002913 34053 61421 ML00002964 36070 61422 ML00002999 37918 61425 ML00003034 39009 61426 ML00003091 39700 62156 ML00003142

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• 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.2018-02-12
• Capio SLIM Box 5, Model #M0068318261; Intended for use in general suturing applications during open surgery to assist in the placement of suture material in tissues at the operative site.2018-02-12
• Capio CL; Model #M0068311350. Indicated for the placement of suture in a variety of Transvaginal procedures.2018-02-12
• 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.2018-02-12
• 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.2018-02-12

All FDA (Device enforcement) recalls