Capio SLIM Box 5, Model #M0068318261; Intended for use in general suturing applications durin...
FDA Device Recall #Z-1617-2018 — Class II — February 12, 2018
Recall Summary
| Recall Number | Z-1617-2018 |
| 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 | 60,538 |
Product Description
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.
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: 19083076 19490462 20703048 19138102 19575737 20703101 19138104 19579790 20706387 20552143 19583816 20779052 20552145 19588973 20786955 20552147 19604718 20838609 20552300 19715051 20838611 19138106 19720437 20838613 19138108 19730190 20838615 19334997 19760389 20838617 20552153 19818985 20838619 17685429 19825371 20838661 17689642 19868166 20838663 17774102 19868170 20838665 17777555 19873851 20838667 17792395 19873853 20838670 17899922 19945906 20902946 17906429 19950376 20908772 17907124 19965002 20908774 17907855 19998515 20908776 17915689 20000798 20908778 17919851 20001166 20923178 17920787 20005049 20933960 17985873 20061149 20933962 17990901 20061151 20968696 17995421 20061153 20971515 17997519 20061155 20978294 18001945 20078729 21058901 18005330 20079183 21135392 18024683 20179283 21149060 18036357 20179505 21153916 18104991 20183190 21153918 18111726 20183193 21238940 18115409 20189154 21240810 18120488 20196783 21244374 18212832 20260976 21244755 18217456 20275824 21246277 18221332 20300581 21246370 18222053 20300685 21277765 18295603 20300689 21278301 18299439 20300692 21347579 18388438 20305782 21347701 18394085 20331414 21358289 18396171 20331416 21360859 18399797 20331418 21366235 18410457 20355333 21386338 18414187 20359462 21386740 18498497 20359470 21402640 18500136 20360846 21408533 18513753 20367015 21408536 18517656 20416925 21412229 18518037 20417300 20633990 18626569 20417302 20633992 18642959 20417304 20637803 18645072 20436291 20637805 18648870 20440668 20638061 18673869 20440672 20701932 18737139 20440674 19334999 18795870 20440677 19335461 18849259 20440679 19418628 18852877 20473754 19418630 18915563 20473758 19437992 18921359 20484087 19482938 18929303 20488264 20554655 18938181 20532138 20580835 19027577 20532440 20582262 19027750 20533045 19243606 19027752 20533047 19243608 19027754 20533580 19079309 20533582
Other Recalls from Boston Scientific Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1551-2026 | Class II | EndoVive Safety PEG Kit; Outer Box Material Nu... | Feb 10, 2026 |
| Z-1160-2026 | Class I | AXIOS Stent and Electrocautery-Enhanced Deliver... | Dec 19, 2025 |
| Z-1162-2026 | Class I | *HOT AXIOS Stent and Electrocautery-Enhanced De... | Dec 19, 2025 |
| Z-1159-2026 | Class I | AXIOS Stent and Electrocautery-Enhanced Deliver... | Dec 19, 2025 |
| Z-1163-2026 | Class I | *HOT AXIOS Stent and Electrocautery-Enhanced De... | Dec 19, 2025 |
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.