Capio SLIM recallZ-1616-2018 · Boston Scientific Corporation · initiated Feb 12, 2018

Terminated

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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-1616-2018
Status: Terminated
Initiated by the company: Feb 12, 2018
Posted by the FDA: May 4, 2018
Recalling firm: Boston Scientific Corporation
Quantity: 21,250
Product code: PWI
FDA submissions: K172060
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

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.

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

UDI:08714729842224. Batch numbers: 17781206 19335463 20312941 17782808 19435078 20423794 17790316 19568158 20453711 17792469 19573475 20453712 17986321 19701151 20475301 17991696 19711511 20484084 18106407 19833973 20484085 18110253 19858683 20532136 18213570 19858950 20628943 18304052 19882066 20633409 18384108 19882067 20637817 18407974 19887279 20693087 18420687 19942844 20697608 18492494 19959781 20838671 18494737 19963492 20838674 18620481 19993297 20838675 18740238 20000796 20838676 18792184 20001160 20902944 18855259 20001161 20968694 18922488 20006757 21065530 18925301 20009446 21135395 19027722 20017944 21166978 19138109 20202691 21168424 19173080 20203473 21168425 19243603 20305797 21258657 19243604 20305799 21362103 19335462 20305920 21386335

Devices named in this recall

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

Capio SLIM M0068318260
Boston Scientific Corporation · Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse
3 recalls282 reports

Product lines

Capio SLIMBoston Scientific Corporation · 2 models · 478 reports · 4 recalls

Other products in the same recall event

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

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.
Z-1622-2018 · Terminated
Uphold LITE w/ Capio SLIM; Model #M0068318170. Indicated for tissue reinforcement in women with pelvic organ prolapse.

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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