CLASS II ONGOING Device recall · Reported 11 Oct 2023 · FDA Enforcement Report

Veran : Percutaneous Always on Track recalled

Olympus Corporation of the Americas is recalling Veran : Percutaneous Always on Track, distributed nationwide in the US. The recall was initiated on 10 Aug 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel-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

Quantity recalled522 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2663-2023
FDA event ID: 92893
Recalling firm: Olympus Corporation of the Americas, Center Valley, PA
Classification: Class II
Status: Ongoing
Recall initiated: 10 Aug 2023
FDA classified: 29 Sep 2023
Reported: 11 Oct 2023
Type: Voluntary: Firm initiated
Customers notified by: N/A
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

10 Aug 2023	Recall initiated by company
29 Sep 2023	Classified by FDA	+50 days
11 Oct 2023	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Product as listed by the FDA

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

Where it was distributed

Worldwide distribution - US Nationwide and the countries of CN, DE, HK, IT, KR, SG, TH, TW.

Nationwide Delaware

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

Worldwide distribution - US Nationwide and the countries of CN, DE, HK, IT, KR, SG, TH, TW.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

5 other products · FDA event 92893

This product is part of a recall event; the main page for the event is Veran : Endobronchial Always on Track recalled.

Reported	Class	Recall	Company	Reason	Where
11 Oct 2023	CLASS II	Veran : Endobronchial Always on Track recalled	Olympus Corporation of the Americas	Other	Nationwide
11 Oct 2023	CLASS II	Veran:SPiN Thoracic Navigation System recalled	Olympus Corporation of the Americas	Other	Nationwide
11 Oct 2023	CLASS II	Veran : Percutaneous recalled by Olympus Corporation of the	Olympus Corporation of the Americas	Other	Nationwide
11 Oct 2023	CLASS II	Veran : Endobronchial recalled by Olympus Corporation of the	Olympus Corporation of the Americas	Other	Nationwide
11 Oct 2023	CLASS II	Veran Endobronchial recalled by Olympus Corporation of the	Olympus Corporation of the Americas	Other	Nationwide

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