Uphold LITE w/ Capio SLIM recallZ-1622-2018 · Boston Scientific Corporation · initiated Feb 12, 2018

Why it was recalled

Potential for Capio sutures to break and /or detach.

FDA root cause category: Device Design

What the company is doing

Boston Scientific sent Urgent Medical Device Correction letters, dated February 12, 2018, to customers via FED-EX two day delivery. Customers were informed of the updates to the affected product instructions for use and advised to read the notification carefully and immediately post the information in a visible location near the product to ensure it is easily accessible to all users of the device. Also, the notification should be passed on to any health professional of the customer's organization that needs to be aware and to any organization where the potentially affected devices have been transferred. Customers with questions should contact their local BSC (Boston Scientific) Representative. **No product is being recalled and you are not required to return product to Boston Scientific** There is no impact to previously implanted mesh devices.

Recall details

Recall number

Z-1622-2018

Status

Terminated

Initiated by the company

Feb 12, 2018

Posted by the FDA

May 4, 2018

Recalling firm

Boston Scientific Corporation

Quantity

24,126

Product code

PWI

FDA submissions

K122459

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, Islamic Republic of Iran, El Salvador, Colombia, New Zealand, Belgium, Germany, Jordan, Norway, Russia, Pakistan, Slovakia, Portugal, South Africa, Oman, Saudi Arabia, Poland, Slovenia, Qatar, Spain, Kenya, Lebanon, Mauritius, Netherlands, Sweden, Turkey, Kuwait, Malta, Namibia, Romania, Switzerland, and Greece.

Product description

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• Uphold™ LITE M0068318170

  Boston Scientific Corporation · Mesh, surgical, synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed
  1 recall459 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 79608).

• Z-1616-2018 · Terminated
  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 tiss…
• Z-1617-2018 · Terminated
  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 operat…
• Z-1618-2018 · Terminated
  Capio CL; Model #M0068311350. Indicated for the placement of suture in a variety of Transvaginal procedures.
• Z-1619-2018 · Terminated
  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 m…
• Z-1620-2018 · Terminated
  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 mater…
• Z-1621-2018 · Terminated
  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.