NC Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide. Packaged in the f...
FDA Device Recall #Z-0579-2020 — Class II — October 24, 2019
Recall Summary
| Recall Number | Z-0579-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 24, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Boston Scientific Corporation |
| Location | Maple Grove, MN |
| Product Type | Devices |
| Quantity | 14,145 devices total |
Product Description
NC Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493926708350, NC EMERGE MR US 3.50MM X 8MM; 2. REF/Catalog No. H7493927608350, NC EMERGE MR OUS 3.50MM X 8MM; 3. REF/Catalog No. H7493927608400, NC EMERGE MR OUS 4.00MM X 8MM; 4. REF/Catalog No. H7493927612200, NC EMERGE MR OUS 2.00MM X 12MM; 5. REF/Catalog No. H7493926712250, NC EMERGE MR US 2.50MM X 12MM; 6. REF/Catalog No. H7493927612250, NC EMERGE MR OUS 2.50MM X 12MM; 7. REF/Catalog No. H7493926712270, NC EMERGE MR US 2.75MM X 12MM; 8. REF/Catalog No. H7493926712320, NC EMERGE MR US 3.25MM X 12MM; 9. REF/Catalog No. H7493927612350, NC EMERGE MR OUS 3.50MM X 12MM; 10. REF/Catalog No. H7493926712400, NC EMERGE MR US 4.00MM X 12MM; 11. REF/Catalog No. H7493927612500, NC EMERGE MR OUS 5.00MM X 12MM; 12. REF/Catalog No. H7493927615270, NC EMERGE MR OUS 2.75MM X 15MM; 13. REF/Catalog No. H7493926715300, NC EMERGE MR US 3.00MM X 15MM; 14. REF/Catalog No. H7493927615300, NC EMERGE MR OUS 3.00MM X 15MM; 15. REF/Catalog No. H7493927615320, NC EMERGE MR OUS 3.25MM X 15MM; 16. REF/Catalog No. H7493926715350, NC EMERGE MR US 3.50MM X 15MM.
Reason for Recall
Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during the manufacturing process.
Distribution Pattern
Nationwide including Washington D.C. and Puerto Rico. OUS to include Canada.
Lot / Code Information
Lot / GTIN Number / Use By: 1. 21333639 / 8714729846284 / 2019-11-03. 2. 23808016 / 8714729847007 / 2021-05-16. 3. 21865055 / 8714729847021 / 2020-03-14. 4. 24119885 / 8714729847076 / 2021-07-16. 5. 23541260 / 8714729846376 / 2021-03-25. 6. 22119751 / 8714729847090 / 2020-05-14. 7. 22294873 / 8714729846383 / 2020-06-24. 8. 24119876 / 8714729846406 / 2021-07-21. 9. 23479019 /8714729847137 / 2021-03-12 , 23874443 / 8714729847137 / 2021-05-29, 24133485 / 8714729847137 / 2021-07-18. 10. 23998680 / 8714729846437 / 2021-06-23. 11. 22690879 / 8714729847175 / 2020-09-21. 12. 23511693 / 8714729847236 / 2021-03-19, 23584725 / 8714729847236 / 2021-04-02. 13. 21327739 / 8714729846529 / 2019-11-02. 14. 23436304 / 8714729847243 / 2021-03-04, 23541268 / 8714729847243 / 2021-03-25. 15. 23931831 / 8714729847250 / 2021-06-10. 16. 23998683 / 8714729846543 / 2021-06-21.
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.