INDY OTW VASCULAR RETRIEVER
Received Jul 28, 2026 · Event occurred Jul 21, 2026
Report 1820334-2026-00766 · MDR key 50055129
Device
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It was reported that foreign matter was identified in the sealed packaging of the Indy OTW Vascular Retriever. A hair like foreign matter was identified visually before delivery to the hospital.
Additional Manufacturer Narrative
E1 - Country: JapanH3 - Device evaluation anticipated but not yet begun. Awaiting device return.This report includes information known at this time. A follow-up report will be submitted should additional relevant information become available.This report is required by the FDA under 21 CFR Part 803. This report is based on unconfirmed information submitted by others. Neither the submission of this report nor any statement made in it is intended to be an admission that any Cook device is defective or malfunctioned; that a death or serious injury occurred; or that any Cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.