Cook G05880Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002058804), received between Jul 20, 2017 and Dec 13, 2019 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Contamination” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 13, 2019Flaked; Flaked

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Code Available

  MAUDE report 9468313 ↗
• MalfunctionMar 25, 2019Contamination; Contamination

  IT WAS REPORTED IN ADDITIONAL INFORMATION RECEIVED ON 31MAR2019 THAT THE PARTICLES WERE NOTICED AFTER THE EXCHANGE PROCEDURE WAS COMPLETED AND THAT THE PARTICLES WERE FOUND TO BE STUCK ON THE DEVICE. THE DEVICE WAS RETURNED FOR EVALUATION ON 02APR2019, AND IT WAS FOUND DURING PRELIMINARY ANALYSIS THAT THE CATHETER AND BALLOON WERE SPLIT IN ADDITION TO RED PARTICLES THAT WERE NOTED UPON VISUAL EXAMINATION. THE BACK END WAS SLIGHTLY FLARED, INDICATING A FITTING SHOULD BE PRESENT. IT WAS ALSO NOTED DURING THE INVESTIGATION THAT THE DEVICE RETURNED WAS NOT A COOK DEVICE. A REQUEST TO RETURN THE CORRECT DEVICE WAS MADE TO THE CUSTOMER. IT WAS LATER REPORTED ON 10APR2019 THAT THE DEVICE INVOLVED IN THE INCIDENT WAS NOT A COOK PRODUCT. A DEVICE FROM ANOTHER MANUFACTURER WAS RETURNED BY THE CUSTOMER IN COOK OUTER PACKAGING BY MISTAKE. THE DEVICE WILL BE RETURNED TO THE CUSTOMER. THEREFORE, THIS EVENT IS NOT REPORTABLE UNDER FDA 21 CFR PART 803 AS THE REPORTED DEVICE IS NOT MANUFACTURED OR MARKETED BY COOK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8448382 ↗
• InjurySep 26, 2017Failure to Advance; Device Damaged by Another Device; Failure to Advance; Device Damaged by Another Device

  THE INTERNATIONAL CUSTOMER REPORTED THAT, DURING A THORACOTOMY PROCEDURE, THE COOK AIRWAY EXCHANGE CATHETER WAS EMPLOYED IN THE REPLACING OF THE INTUBATION TUBES. THE CATHETER WENT INTO THE INTUBATION TUBE, BUT REPORTEDLY GOT STUCK AFTER 10 CM OF DEPTH, AND WOULD NOT ADVANCE FURTHER INTO THE TUBE. THE CATHETER WAS THEN PULLED FROM THE TUBE, AND THE PATIENT WAS RECONNECTED TO THE RESPIRATOR. THE OPERATOR SUBSEQUENTLY OBSERVED THAT THE RESPIRATOR HAD A YELLOW PLASTIC "MARK/PIECE" [SIC] THAT HAD PEELED OFF OF THE EXCHANGE CATHETER. A SUCTION CATHETER WAS EMPLOYED IN AN ATTEMPT TO REMOVE IT, WITHOUT SUCCESS. ANOTHER PLASTIC PIECE FROM THE CATHETER WAS ALSO FOUND N THE PATIENT'S LUNG, AND IT TOOK 30 MINUTES TO REMOVE IT. THE CUSTOMER CONFIRMED THAT THE PRODUCT IS AVAILABLE FOR RETURN; HOWEVER, AS OF THE DATE OF THIS REPORT, NO PRODUCT HAS YET BEEN RECEIVED FOR EVALUATION.

  Patient problems: No Code Available

  MAUDE report 6894290 ↗
• MalfunctionJul 20, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  DISTRIBUTOR REPORTED THAT THERE WAS A PIECE OF AN UNIDENTIFIED PARTICLE INSIDE THE PRIMARY PACKAGE OF A COOK AIRWAY EXCHANGE CATHETER. THE EVENT WAS NOTED DURING INCOMING PRODUCT INSPECTION. THERE WAS NO PATIENT CONTACT, ACCORDINGLY THERE ARE NO ADVERSE PATIENT CONSEQUENCES. THE DEVICE IS AVAILABLE FOR EVALUATION.

  Patient problems: No Patient Involvement

  MAUDE report 6727877 ↗