Cook G07873Recalls & reported problems
Cook Incorporated · Cook Airway Exchange Catheter · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002078734), received between Sep 12, 2017 and Sep 12, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Material Fragmentation” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Material Fragmentation1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 12, 2017Material Fragmentation; Material Fragmentation
IT WAS REPORTED BY THE INTERNATIONAL CUSTOMER THAT, APPROXIMATELY ONE MONTH FOLLOWING A PROCEDURE IN WHICH A COOK AIRWAY EXCHANGE CATHETER WAS EMPLOYED, THE PATIENT REPORTED THAT THEY COUGHED UP A PIECE OF YELLOW TUBING. THE PATIENT REPORTED THIS ISSUE DURING A SCHEDULED, POST-PROCEDURE MEDICAL CHECKUP. THE TUBE HAD REPORTEDLY BEEN POSITIONED FOR EXTUBATION DURING THE ORIGINAL PROCEDURE, AND WAS REMOVED 15 MINUTES AFTER THE EXTUBATION WAS COMPLETE. THE CIRCUMSTANCES SURROUNDING THE USAGE AND HANDLING OF THE DEVICE ARE NOT FULLY KNOWN. THE DEVICE IS REPORTEDLY UNAVAILABLE FOR RETURN.
Patient problems: Foreign Body In Patient
MAUDE report 6857375 ↗
Other INSTRUMENT, ENT MANUAL SURGICAL devices
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- n.a. 723014Karl Storz GmbH & Co. KG · INSTRUMENT, ENT MANUAL SURGICAL1 recall0 reports
- n.a. 738752Karl Storz GmbH & Co. KG · INSTRUMENT, ENT MANUAL SURGICAL1 recall0 reports
- n.a. 810506Karl Storz GmbH & Co. KG · INSTRUMENT, ENT MANUAL SURGICAL1 recall0 reports
- n.a. 810505Karl Storz GmbH & Co. KG · INSTRUMENT, ENT MANUAL SURGICAL1 recall0 reports
- n.a. 723400Karl Storz GmbH & Co. KG · INSTRUMENT, ENT MANUAL SURGICAL1 recall0 reports
- n.a. 738758Karl Storz GmbH & Co. KG · INSTRUMENT, ENT MANUAL SURGICAL1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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