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Capio SLIM Suture Capturing Device, Model #M0068318250. Intended for use in general suturing a...

FDA Device Recall #Z-1616-2018 — Class II — February 12, 2018

Recall Summary

Recall Number Z-1616-2018
Classification Class II — Moderate risk
Date Initiated February 12, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Boston Scientific Corporation
Location Marlborough, MA
Product Type Devices
Quantity 21,250

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.

Reason for Recall

Potential for Capio sutures to break and /or detach.

Distribution Pattern

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.

Lot / Code Information

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

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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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