Boston Scientific Corporation: Uphold Vaginal Support System; Model #M0068317080. Indicated for tissue reinforcement in women with pelvic organ prolapse.

Is my product affected?

Uphold Vaginal Support System; Model #M0068317080. Indicated for tissue reinforcement in women with pelvic organ prolapse.

• UPC 08714729773955

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

What happened

Boston Scientific Corporation is recalling 1,002 units of the Uphold Vaginal Support System (Model #M0068317080) worldwide due to a potential for Capio sutures to break and/or detach. This device is used for tissue reinforcement in women with pelvic organ prolapse. The affected units were distributed to numerous countries including the United States, Canada, Mexico, and many others across Europe, Asia, South America, and the Middle East.

The recall affects specific batch numbers: ML00002892, ML00003166, ML00003060, ML00003291, ML00003119, ML00003435, and ML00003516 (GTIN: 08714729773955). The source document does not specify a remedy or recommended consumer action.

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: 1,002 Lot/code info: GTIN: 08714729773955. Batch numbers: ML00002892 ML00003166 ML00003060 ML00003291 ML00003119 ML00003435 ML00003516

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