Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX /150CM UPN: M0066703061 box 5 UPN: M00...
FDA Device Recall #Z-1730-2020 — Class II — March 9, 2020
Recall Summary
| Recall Number | Z-1730-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 9, 2020 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Boston Scientific |
| Location | Marlborough, MA |
| Product Type | Devices |
| Quantity | 1,785 |
Product Description
Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX /150CM UPN: M0066703061 box 5 UPN: M0066703060 single unit
Reason for Recall
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
Distribution Pattern
Nationwide Foreign: Europe, Middle East and Africa, the Americas (North America and South America, Asia Pacific and Japan
Lot / Code Information
Lot Numbers: 24484631, 24494135, 24494288, 24533782, 24584655, 24617736, 24625474, 24665994, 24723912
Other Recalls from Boston Scientific
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1734-2020 | Class II | Percuflex Plus Ureteral Stent Set 6FX26CM with ... | Mar 9, 2020 |
| Z-1740-2020 | Class II | Polaris Ultra Ureteral Stent Set 6FX24CM with .... | Mar 9, 2020 |
| Z-1732-2020 | Class II | Sensor Nitinol Wire with Hydrophilic Tip .0383C... | Mar 9, 2020 |
| Z-1738-2020 | Class II | Stretch VL Ureteral Stent Set 6FX22- 30CM with ... | Mar 9, 2020 |
| Z-1731-2020 | Class II | Sensor Nitinol Wire with Hydrophilic Tip .038 3... | Mar 9, 2020 |
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.