Cook G06732Recalls & reported problems
Cook Incorporated · Cook Airway Exchange Catheter · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002067325), received between Feb 2, 2021 and Sep 23, 2024 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break1
- Device Contaminated During Manufacture or Shipping1
- Material Separation1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
- No Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20287592 ↗InjuryMay 16, 2023Material Separation; Material Separation
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Foreign Body In Patient
MAUDE report 16939817 ↗MalfunctionFeb 2, 2021Break; Break
IT WAS REPORTED THAT A COOK AIRWAY EXCHANGE CATHETER BROKE DURING A PROCEDURE IN THE INTENSIVE CARE UNIT (ICU). ADDITIONAL DETAILS REGARDING THE EVENT HAVE BEEN REQUESTED, BUT ARE CURRENTLY UNAVAILABLE.
Patient problems: No Information
MAUDE report 11265736 ↗
Other INSTRUMENT, ENT MANUAL SURGICAL devices
- n.a. 738756Karl Storz GmbH & Co. KG · INSTRUMENT, ENT MANUAL SURGICAL1 recall0 reports
- n.a. 738750Karl Storz GmbH & Co. KG · INSTRUMENT, ENT MANUAL SURGICAL1 recall0 reports
- 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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