The Recall Desk
HighFDA (Devices)·Z-2660-2023·Announced 2023-10-11

Veran Endobronchial Navigation Devices Recalled for Manufacturing Non-conformance

Olympus is recalling Veran endobronchial navigation devices (6,484 units) worldwide due to manufacturing non-conformances and insufficient evidence of adequate electromagnetic compatibility. The devices may not function acceptably in environments with electromagnetic interference.

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: This is an FDA Class II medical device recall with manufacturing non-conformances and insufficient electromagnetic compatibility evidence. While no illnesses or injuries are reported, the devices are used in invasive bronchial procedures where malfunction due to electromagnetic interference could cause patient harm. This qualifies as a risk-of-harm product without reported injury.

Plain-English summary

Olympus Corporation of the Americas is recalling 6,484 Veran endobronchial navigation devices, including SPiN Access Catheters and SPiN EWC Biopsy Guide Kits in multiple models designed for use with Pentax and Olympus bronchoscopes. All serial numbers and lot numbers of the affected models are included in this recall.

The recall is due to manufacturing non-conformances to design requirements and insufficient evidence of 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 in its operating environment. The insufficient EMC evidence means the devices may not function properly if exposed to electromagnetic interference during use.

The affected devices were distributed worldwide, including throughout the United States and internationally to China, Germany, Hong Kong, Italy, South Korea, Singapore, Thailand, and Taiwan.

Users of these devices should contact Olympus Corporation of the Americas for information regarding device replacement or corrective actions.

The recalled product

Product
Veran Endobronchial: Models: INS-5925 SPiN Access Catheter¿ 180 Degree for use w/ Pentax Scopes INS-5920 SPiN Access Catheter¿ 90 Degree for use w/ Pentax Scopes INS-5915 SPiN Access Catheter¿ 180 for use w/ Olympus Scopes INS-5910 SPiN Access Catheter¿ 90 for u
Manufacturer
Olympus Corporation of the Americas
Category
Medical Device — Bronchial Navigation
Hazard
  • manufacturing-non-conformance
  • electromagnetic-interference
  • device-malfunction

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 (2)

  • INS-5915 SPiN Access Catheter¿ 180 for use w/ Olympus Scopes 00815686021290
  • INS-5905 SPiN Access Catheter¿ 180 for use w/ Olympus Scopes 00815686021269

Distribution

Distributed nationwide across the United States.

Related recalls

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