VersaOne Reusable Positioning Cannula 8 mm Standard, Model Number RC8STS
FDA Device Recall #Z-1463-2023 — Class II — March 22, 2023
Recall Summary
| Recall Number | Z-1463-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 22, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Covidien LP |
| Location | Mansfield, MA |
| Product Type | Devices |
| Quantity | 145 units |
Product Description
VersaOne Reusable Positioning Cannula 8 mm Standard, Model Number RC8STS
Reason for Recall
There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside of the VersaOneTM Reusable Positioning Cannula, located where the Cannula and Body components are welded together.
Distribution Pattern
Worldwide - US Nationwide distribution in the states of NC and the countries of Belgium, Denmark, France, Germany, India, Italy, Netherlands, Spain, Sweden.
Lot / Code Information
UDI-DI: 10884521784024; Serial Numbers: C21RAE0063 C21RAE0064 C21RAE0065 C21RAE0072 C21RAE0074 C21RAE0032 C21RAE0033 C21RAE0035 C21RAE0036 C21RAE0037 C21RAE0039 C21RAE0054 C21RAE0055 C21RAE0062 C21RAE0073 C21RAE0075 C21RAH0001 C21RAH0002 C21RAH0003 C21RAH0004 C21RAH0005 C21RAE0051 C21RAE0052 C21RAE0053 C21RAK0024 C21RAK0025 C21RAK0026 C21RAE0044 C21RAE0045 C21RAH0012 C21RAH0017 C21RAH0018 C21RAH0019 C21RAH0020 C21RAK0001 C21RAK0002 C21RAK0003 C21RAK0004 C21RAK0005 C21RAK0007 C21RAK0012 C21RAK0013 C21RAK0014 C21RAH0006 C21RAH0007 C21RAH0008 C21RAH0009 C21RAH0010 C21RAH0011 C21RAK0006 C21RAK0010 C21RAK0011 C21RAG0006 C21RAG0007 C21RAG0008 C21RAG0009 C21RAG0010 C21RAG0011 C21RAG0012 C21RAG0013 C21RAG0014 C21RAG0015 C21RAG0016 C21RAG0017 C21RAG0018 C21RAG0019 C21RAG0020 C21RAH0016 C21RAK0021 C21RAK0022 C21RAK0023 C21RAK0027 C21RAK0028 C21RAB0023 C21RAB0024 C21RAB0025 C21RAE0001 C21RAE0002 C21RAE0003 C21RAE0004 C21RAE0005 C21RAE0006 C21RAE0007 C21RAE0008 C21RAE0009 C21RAK0029 C21RAK0030 C21RAK0031 C21RAK0042 C21RAK0043 C21RAK0044 C21RAK0045 C21RAL0001 C21RAL0002 C21RAL0003 C21RAL0004 C21RAL0005 C21RAL0006 C21RAL0007 C21RAL0008 C21RAL0009 C21RAM0001 C21RAM0002 C21RAM0005 C21RAM0006 C21RAM0042 C21RAM0048 C21RAM0052 C21RAM0053 C21RAM0091 C21RAM0092 C21RAM0093 C21RAM0094 C21RAM0095 C21RAM0096 C21RAM0097 C21RAM0098 C21RAM0099 C21RAM0057 C21RAM0058 C21RAM0060 C21RAM0061 C21RAM0062 C21RAM0063 C21RAM0064 C21RAM0065 C21RAM0066 C21RAM0067 C21RAM0068 C21RAM0069 C21RAK0032 C21RAK0033 C21RAK0034 C21RAK0035 C21RAK0036 C21RAK0037 C21RAK0038 C21RAK0040 C21RAK0041 C21RAM0079 C21RAM0080 C21RAM0081 C21RAM0082 C21RAM0083 C21RAM0084
Other Recalls from Covidien LP
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0257-2025 | Class II | Chameleon PTA Balloon Catheter with Injection P... | Sep 19, 2024 |
| Z-1635-2024 | Class II | Palindrome Precision H Chronic Catheter Kit 1... | Mar 15, 2024 |
| Z-1634-2024 | Class II | Palindrome Precision HSI Chronic Catheter Sport... | Mar 15, 2024 |
| Z-0844-2024 | Class II | Surgilon Braided Nylon sutures: 88861919-31 ... | Dec 21, 2023 |
| Z-0845-2024 | Class II | Sofsilk Braided Silk sutures: CS-211 SOFSILK* ... | Dec 21, 2023 |
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.