The Recall Desk
HighFDA (Devices)·Z-2663-2023·Announced 2023-10-11

Veran Navigation System Biopsy Needle Devices: Electromagnetic Compatibility Issue

Olympus is recalling 522 units of Veran navigation system biopsy needles due to manufacturing defects and insufficient electromagnetic compatibility testing. Devices may not function properly in certain electromagnetic environments.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall affecting a medical device used during patient procedures; non-conformances in manufacturing and electromagnetic compatibility present a risk of harm in the operating environment. No injuries or adverse events have been reported, limiting the score to 3 per the rubric's rule that theoretical hazards without reported harm score at most 3.

Plain-English summary

Olympus Corporation of the Americas is recalling 522 units of the Veran Percutaneous Always on Track navigation system and associated biopsy needles due to manufacturing defects and insufficient electromagnetic compatibility (EMC) evidence.

The devices have non-conformances in manufacturing that do not meet design specifications. Additionally, the manufacturer has not provided sufficient evidence demonstrating that the equipment functions acceptably in electromagnetic environments without causing or experiencing interference with other devices. Electromagnetic compatibility is critical for medical devices used during patient procedures to ensure reliable operation.

Affected devices are distributed in the United States and internationally in China, Germany, Hong Kong, Italy, South Korea, Singapore, Thailand, and Taiwan. All serial numbers and lot numbers of the affected products are included in this recall.

Healthcare providers and patients with these devices should contact their healthcare facility or Olympus Corporation of the Americas for instructions regarding device handling, replacement, or other remediation options.

The recalled product

Product
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
Manufacturer
Olympus Corporation of the Americas
Category
Medical Device — Surgical Navigation System
Hazard
  • manufacturing-defect
  • electromagnetic-interference

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

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