Agency classClass IIOur severity:High FDA (Devices)·Z-2662-2023·Announced 2023-10-11

Veran Endobronchial Navigation Devices Recalled for Design Non-Conformance and EMC Issues

Olympus Corporation recalls Veran endobronchial navigation devices due to manufacturing non-conformances and insufficient electromagnetic compatibility. Approximately 6,318 units distributed worldwide are affected.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: The devices are Class II medical devices with manufacturing non-conformance and insufficient electromagnetic compatibility evidence, but no reported injuries or hospitalizations. Per the severity rubric, this qualifies as High because it is a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Olympus Corporation of the Americas is recalling Veran endobronchial navigation system components, including the ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and associated navigation instruments. Approximately 6,318 units have been distributed worldwide, including throughout the United States and in China, Germany, Hong Kong, Italy, South Korea, Singapore, Thailand, and Taiwan.

The recall was issued because the devices contain non-conformances in manufacturing that do not meet design requirements. Additionally, there is insufficient evidence demonstrating that the devices adequately meet electromagnetic compatibility (EMC) standards. Electromagnetic compatibility is the ability of electrical equipment to function acceptably without causing or experiencing interference from other electrical devices in the operating environment.

Healthcare providers currently using these Veran devices should contact Olympus Corporation for further information regarding the manufacturing non-conformance and available options. The FDA classified this as a Class II recall.

The recalled product

Product: Veran : Endobronchial Models: INS-5500 View Optical Probe INS-5450 SPiN Xtend¿ 21ga, 1.8 OD, 5/Bx INS-5440 View Peripheral Catheter, 3.8mm OD, 2.5mm WC INS-5411 0.016" Stylet, 1235 mm L, 10/Bx INS-5410 SPiN Flex¿ ANSO¿ Needle, 22ga, 1.8mm OD, 5/Bx…
Manufacturer: Olympus Corporation of the Americas
Category: Medical Device — Surgical Navigation
Hazard: design-non-conformance
electromagnetic-interference
Affected units: 6,318

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 (18)

Model-UDI: INS-5500 View Optical Probe 00815686020729
INS-5450 SPiN Xtend¿ 21ga
1.8 OD
5/Bx 00815686020651
INS-5440 View Peripheral Catheter
3.8mm OD
2.5mm WC 00815686020644
INS-5411 0.016" Stylet
1235 mm L
10/Bx 00815686021191
INS-5410 SPiN Flex¿ ANSO¿ Needle
22ga
1.8mm OD
5/Bx 00815686020637
INS-5323 Sliding stopper 00815686020712
INS-5300 "Always-On Tip Tracked¿ Triple Needle Brush
12mm L
5/Bx" 00815686021207 . All serial numbers and all lot numbers

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 6 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Same manufacturer · Olympus Corporation of the Americas

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Same hazard · design non conformance