The Recall Desk
HighFDA (Devices)·Z-2664-2023·Announced 2023-10-11

Veran Endobronchial Navigation System: Manufacturing and EMC Defects

Olympus is recalling Veran endobronchial navigation systems due to manufacturing non-conformances and insufficient electromagnetic compatibility evidence. Devices may malfunction or interfere with other medical equipment.

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 medical device with manufacturing non-conformances and insufficient EMC evidence affecting a surgical navigation system. No deaths, hospitalizations, or injuries reported. Per rubric, risk-of-harm products without reported injury score High (3).

Plain-English summary

Olympus Corporation of the Americas is recalling the Veran Endobronchial Always-on Track (AOTT) navigation system and associated instruments, including needles, forceps, guidewires, catheters, and tracking devices. The recall affects 60,102 units distributed worldwide, including the United States and internationally to China, Germany, Hong Kong, Italy, South Korea, Singapore, Thailand, and Taiwan.

The recalled devices have manufacturing non-conformances—they do not conform to design requirements. Additionally, there is insufficient evidence demonstrating adequate electromagnetic compatibility (EMC). EMC is the ability for equipment to function acceptably without interference and without interfering with other devices in its operating environment. These defects raise concerns about safe device operation.

Healthcare facilities, surgical centers, and medical providers using the Veran AOTT navigation system for endobronchial procedures are affected. Providers with questions should contact Olympus Corporation of the Americas.

The recalled product

Product
Veran : Endobronchial Always on Track Models: INS-0392 AOTT 21ga Needle, 12mm L, 1.8mm OD, 5/BX INS-0382 AOTT 19ga Needle, 12mm L, 1.8 OD, 5/Bx INS-0372 AOTT Serrated Forceps, 1.8mm OD, 5/Bx INS-0362 AOTT Oval Cup Forceps, 1.8mm OD, 5/Bx INS-0352 "Always
Manufacturer
Olympus Corporation of the Americas
Category
Medical Device — Surgical Navigation System
Hazard
  • manufacturing-defect
  • emc-non-compliance
  • device-malfunction-risk

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)

  • INS-0392 AOTT 21ga Needle
  • 12mm L
  • 1.8mm OD
  • 5/BX 00815686020613
  • INS-0382 AOTT 19ga Needle
  • 1.8 OD
  • 5/Bx 00815686020590
  • INS-0372 AOTT Serrated Forceps
  • 5/Bx 00815686020576
  • INS-0362 AOTT Oval Cup Forceps
  • 5/Bx 00815686020538
  • INS-0352 "Always-On Tip Tracked (AOTT) Brush
  • 15mm L
  • 5/Bx" 00815686020538
  • INS-0322 View Peripheral Catheter
  • 3.2mm OD
  • 2.0mm WC 00815686020477
  • INS-0305 Always-On Tip Tracked Guidewire
  • 1.0mm
  • 950mm 00815686020446

Distribution

Distributed nationwide across the United States.

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