Destination Renal Guiding Sheath Intended for the introduction of interventional and diagnosti...
FDA Device Recall #Z-2033-2017 — Class II — November 6, 2015
Recall Summary
| Recall Number | Z-2033-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 6, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Terumo Medical Corporation |
| Location | Elkton, MD |
| Product Type | Devices |
| Quantity | 5,252 eaches |
Product Description
Destination Renal Guiding Sheath Intended for the introduction of interventional and diagnostic devices into the human vasculature.
Reason for Recall
Based on internal investigation and testing that revealed the distal end of certain lots of Terumo Medical Destination¿ products may not contain the labeled 5 cm of coating. While there have been no complaints or patient related incidents reported, the lack of coating could render it difficult to navigate the device to the target vasculature.
Distribution Pattern
Nationwide Distribution.
Lot / Code Information
Terumo Product Code - RSR01 Affected Lot Numbers RN19 RN26 RP03
Other Recalls from Terumo Medical Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1375-2019 | Class I | SOLOPATH Re-Collapsible Access System, Model Nu... | Apr 26, 2019 |
| Z-1374-2019 | Class I | SOLOPATH Balloon Expandable TransFemoral System... | Apr 26, 2019 |
| Z-1376-2019 | Class I | Portico Solo Re-Collapsible Access System , Mod... | Apr 26, 2019 |
| Z-1999-2019 | Class II | Terumo Sur-vet Needle, 22G x 1", Product Code 1... | Feb 8, 2019 |
| Z-2005-2019 | Class II | Terumo Needle, 23G x 1", Product Code NN2325R | Feb 8, 2019 |
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.