Cook G36401Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002364011), received between Oct 2, 2018 and Nov 12, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 12, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED FOREIGN MATTER, HAIR-LIKE FIBER, WAS FOUND INSIDE THE STERILE PACKAGING OF A COOK DOUBLE LUMEN EXTRA FIRM SOFT TIPPED AIRWAY EXCHANGE CATHETER. AS REPORTED, THIS DEVICE DID NOT MAKE PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 8061639 ↗
• InjuryOct 2, 2018Material Rupture; Material Rupture

  IT WAS REPORTED A COOK DOUBLE LUMEN EXTRA FIRM SOFT TIPPED AIRWAY EXCHANGE CATHETER WAS USED FOR AN ENDOTRACHEAL TUBE EXCHANGE FROM SPIRAL TRACHEA TUBE (8.0 MM) TO TRACHEA TUBE (8.5 MM) ON A PATIENT UNDER RESPIRATORY MANAGEMENT. THE EXCHANGE CATHETER WAS INSERTED INTO THE TRACHEAL TUBE AND UPON ATTEMPTING TO REMOVE THE SPIRAL TRACHEA TUBE, IT COULD NOT BE REMOVED. THE CUSTOMER MANIPULATED THE EXCHANGE CATHETER IN ORDER TO REMOVE THE TRACHEA TUBE AND IN THE PROCESS, THE CATHETER RUPTURED. A SEGMENT OF THE CATHETER, APPROXIMATELY 25 CM, REMAINED IN THE PHARYNX AND WAS RETRIEVED USING FORCEPS. THE PATIENT WAS SUCCESSFULLY INTUBATED. AS REPORTED, THE CUSTOMER DID NOT USE EXCESSIVE FORCE ON THE DEVICE WHILE MANIPULATING IT TO REMOVE THE TRACHEAL TUBE AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 7927446 ↗