Veran : Percutaneous Always on Track Models: INS-5040 Always-On vTrack Universal Tracker, LG 7-...
FDA Device Recall #Z-2663-2023 — Class II — August 10, 2023
Recall Summary
| Recall Number | Z-2663-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 10, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Olympus Corporation of the Americas |
| Location | Center Valley, PA |
| Product Type | Devices |
| Quantity | 522 units |
Product Description
Veran : Percutaneous Always on Track Models: INS-5040 Always-On vTrack Universal Tracker, LG 7-12ga INS-5039 Always-On vTrack Universal Tracker, SM/CL, 12-18ga INS-5036 "22 UTW 125mm Always-On Tip Tracked Biopsy Needle, Trocar point" INS-5034 17 UTW Lg 123mm Always-On Tip Tracked Biopsy Needle, Chiba point 00815686020354 INS-5032 "19 UTW 150mm Always-On Tip Tracked Biopsy Needle, Chiba point" INS-5029 "19 UTW 105 mm Always-On Tip Tracked biopsy needle, Chiba oint" INS-5028 19 UTW 155 mm Always-On Tip Tracked biopsy needle, Chiba point INS-5024 "17ga 150mm Always-On Tip Tracked Biopsy Needle, Chiba point" INS-5023 17ga 100mm Always-On Tip Tracked Biopsy Needle, Chiba point INS-5017 17ga x 155mm Tip Tracked Bx Needle INS-5016 17ga x 155mm Tip Tracked Bx Needle
Reason for Recall
Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and insufficient evidence to demonstrate adequate electromagnetic compatibility (EMC). EMC is the ability of electrical equipment and systems to function acceptably without interference and to not interfere with other devices within its operating environment
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of CN, DE, HK, IT, KR, SG, TH, TW.
Lot / Code Information
Model-UDI: INS-5040 Always-On vTrack Universal Tracker, LG 7-12ga 00815686020705; INS-5039 Always-On vTrack Universal Tracker, SM/CL, 12-18ga 00815686020699; INS-5036 "22 UTW 125mm Always-On Tip Tracked Biopsy Needle, Trocar point" 00815686020361; INS-5034 17 UTW Lg 123mm Always-On Tip Tracked Biopsy Needle, Chiba point 00815686020354; INS-5032 "19 UTW 150mm Always-On Tip Tracked Biopsy Needle, Chiba point" 00815686020330; INS-5029 "19 UTW 105 mm Always-On Tip Tracked biopsy needle, Chiba point" 00815686020309; INS-5028 19 UTW 155 mm Always-On Tip Tracked biopsy needle, Chiba point 00815686020293; INS-5024 "17ga 150mm Always-On Tip Tracked Biopsy Needle, Chiba point" 00815686020255; INS-5023 17ga 100mm Always-On Tip Tracked Biopsy Needle, Chiba point 00815686020248; INS-5017 17ga x 155mm Tip Tracked Bx Needle 00815686020224; INS-5016 17ga x 155mm Tip Tracked Bx Needle 00815686020217; All serial numbers and all lot numbers
Other Recalls from Olympus Corporation of the Americas
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1641-2026 | Class II | Brand Name: Olympus HALO PKS Cutting Forceps, 5... | Feb 25, 2026 |
| Z-1640-2026 | Class II | Brand Name: Olympus PK Cutting Forceps, 5mm 33c... | Feb 25, 2026 |
| Z-1642-2026 | Class II | Brand Name: Olympus PKS Cutting Forceps, 5mm 33... | Feb 25, 2026 |
| Z-1639-2026 | Class II | Brand Name: Olympus Everest Bipolar Cutting For... | Feb 25, 2026 |
| Z-1643-2026 | Class II | Brand Name: Olympus PKS Cutting Forceps w/Cord,... | Feb 25, 2026 |
Frequently Asked Questions
Contact your physician immediately if you use an electrical device or implant affected by this recall. For external devices (monitors, pumps), stop using the device and contact the manufacturer for a replacement. For implanted devices (pacemakers, ICDs), your cardiologist will assess whether you need device replacement surgery — the decision depends on how dependent you are on the device and the actual failure rate observed in the field. Do not attempt to repair or modify a recalled electrical medical device yourself. Monitor for any new or unusual symptoms and report them to your doctor.
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.