Contour VL Variable Length Ureteral Stent, UPN M0061801550, M0061801560, M0061801570

FDA Device Recall #Z-0757-2021 — Class II — November 16, 2020

Recall Summary

Recall Number Z-0757-2021
Classification Class II — Moderate risk
Date Initiated November 16, 2020
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Boston Scientific Corporation
Location Marlborough, MA
Product Type Devices
Quantity 458 units

Product Description

Contour VL Variable Length Ureteral Stent, UPN M0061801550, M0061801560, M0061801570

Reason for Recall

Trace amounts of metallic debris were found on the stent related to the manufacturing process. The debris was confirmed to be particles of nickel.

Distribution Pattern

Distribution US nationwide and Japan.

Lot / Code Information

GTIN 08714729058410: Lots 25578577, 25598812, 25609220, 25614542, 25614545, 25619687, 25641771, 25713852, 25753933, 25790349. GTIN 08714729067986: Lots 25640715, 25670518, 25686790, 25686791, 25686792, 25741763, 25741770, 25753937, 25790351, 25795704, 25802759, 25809481, 25822104. GTIN 08714729068020: Lots 25578740, 25583824.

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.