Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101050, GTIN: 08714729192268 ...
FDA Device Recall #Z-1103-2018 — Class II — December 12, 2017
Recall Summary
| Recall Number | Z-1103-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 12, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Boston Scientific Corporation |
| Location | Marlborough, MA |
| Product Type | Devices |
| Quantity | 2614 |
Product Description
Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101050, GTIN: 08714729192268 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography " Pressure/perfusion study (Whitaker test) Therapeutic Indications: " Nephrostomy catheter drainage " Perfusion chemolysis of renal stones " Percutaneous nephrolithotomy " Percutaneous resection and coagulation of urothelial tumors
Reason for Recall
Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.
Distribution Pattern
Worldwide Distribution: US (nationwide) in the following: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KA, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, including the District of Columbia and Puerto Rico; and countries of: Argentina, Bolivia, Brazil, Canada, Chile, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Mexico, Panama, Peru, Venezuela, Australia, Bangladesh, Botswana, China, Kuwait, Lebanon, Macau, Malaysia, Philippines, Saudi Arabia, Singapore, South Africa, South Korea, Turkey, United Arab Emirates, and Zimbabwe.
Lot / Code Information
Expiration Date Range: 1/14/2018 - 10/9/2021; Batch: 16661359 18712075 20198264 16749367 18773340 20312730 16806828 18833032 20350212 16861193 18876338 20425132 17108329 18932471 20491746 17184858 19066695 20517722 17207012 19157075 20624080 17226842 19235547 20653111 17263721 19389756 20703430 17303885 19468061 20740699 17624941 19515681 20769253 17642196 19596299 20884299 17785597 19879546 20942364 17858548 19962558 20968667 17960226 19992214 20995564 18095912 20017161 21046941 18196369 20065717 21071138 18220028 20119217 21157954 18351957 20169832 21241250 18484526
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|---|---|---|---|
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| Z-2048-2026 | Class II | LUX-DX II, Arrythmia detector and alarm, Model ... | Mar 30, 2026 |
| Z-1770-2026 | Class I | Boston Scientific Pacemaker, Implantable Pulse ... | Mar 19, 2026 |
| Z-1771-2026 | Class I | Boston Scientific Cardiac Resynchronization The... | Mar 19, 2026 |
| Z-1551-2026 | Class II | EndoVive Safety PEG Kit; Outer Box Material Nu... | Feb 10, 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.