Approach CTO Micro Wire Guide, Guide Wire, Catalog Prefix CMW; Reference Part Numbers: CMW-14...
FDA Device Recall #Z-0346-2025 — Class II — October 8, 2024
Recall Summary
| Recall Number | Z-0346-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 8, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Cook Incorporated |
| Location | Bloomington, IN |
| Product Type | Devices |
| Quantity | 2,005 US; 1,145 OUS |
Product Description
Approach CTO Micro Wire Guide, Guide Wire, Catalog Prefix CMW; Reference Part Numbers: CMW-14-190-12G CMW-14-190-18G CMW-14-190-25G CMW-14-190-6G CMW-14-300-12G CMW-14-300-18G CMW-14-300-25G CMW-14-300-6G
Reason for Recall
Affected device lots have labels that state the incorrect expiration dates.
Distribution Pattern
Worldwide - US Nationwide distribution.
Lot / Code Information
RPN /UDI-DI/ Lots: CMW-14-190-12G/ 00827002507876/ 15763571 15773059 15783003 15885574 NS15821244 NS15849650 CMW-14-190-18G/ 00827002507883/ 15763579 15769462 15802931 15811662 15898546 15925115 15943888 15974443 15802931X NS15849651 CMW-14-190-25G/ 00827002507890/ 15778254 15791923 15802932 15849652 15891914 15891915 15995205 CMW-14-190-6G/ 00827002507869/ 15800162 15907477 16018911 CMW-14-300-12G/ 00827002507913/ 15718982 15763552 15763561 15763577 15763604 15763605 15794897 15802924 15858395 15858399 15885578 15891916 15898543 15915909 15943896 15945778 15952518 15956556 15958706 NS15843567 NS15892396 CMW-14-300-18G/ 00827002507920/ 15718980 15763553 15763563 15763585 15765959 15794895 15802926 15802933 15835853 15858397 15863270 15891906 15891910 15892397 15900750 15913326 15915903 15915904 15945777 15945781 15958704 15971786 NS15773060 NS15811659 NS15898544 NS15898545 NS15945782 CMW-14-300-25G/ 00827002507937/ 15718981 15731211 15763580 15763591 15763609 15765960 15794896 15800156 15811660 15835856 15863271 15885579 15891911 15892398 15915902 15943887 15943891 15943892 15943897 16018907 NS15821243 NS15945783 NS15974440 NS16006214 NS16025239 CMW-14-300-6G/ 00827002507906/ 15763597 15778251 15794898 15858400 15891908 15907474 15925117 15995202 NS15800160 NS15829388 NS15849653 NS16008457
Other Recalls from Cook Incorporated
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1935-2026 | Class I | Aurous Centimeter Sizing Catheter RPN N5.0-35-... | Apr 2, 2026 |
| Z-1934-2026 | Class I | Centimeter Sizing Catheter RPN N5.0-35-100-P-1... | Apr 2, 2026 |
| Z-1936-2026 | Class I | Beacon Tip Centimeter Sizing Catheter RPN/GPN ... | Apr 2, 2026 |
| Z-1784-2026 | Class II | COOK MEDICAL Cook¿ Strange Bile Duct Stone Expl... | Mar 5, 2026 |
| Z-1780-2026 | Class II | COOK MEDICAL Blue Rhino¿ G2-Multi Percutaneous ... | Mar 5, 2026 |
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.