Halyard 35117Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10680651351170), received between Sep 11, 2019 and Dec 6, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (2 reports).

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 18, 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.

• MalfunctionDec 6, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THE ENDOTRACHEAL (ET) TUBE KINKED DURING USE. THE TUBE WAS REPLACED WITHOUT INCIDENT. THERE WAS NO REPORTED INJURY.

  Patient problems: Extubate

  MAUDE report 9431036 ↗
• MalfunctionSep 11, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THERE WAS DIFFICULTIES IN SUCTIONING THE PATIENT. BOTH OPEN SUCTIONING AND CLOSED SUCTIONING WERE ATTEMPTED. "THE SUCTION CATHETERS WOULD NOT ADVANCE PAST A VERY HIGH POINT AND [THEREFORE] THE PATIENT COULD NOT BE APPROPRIATELY SUCTIONED TO REMOVE SECRETIONS. AN ANATOMICAL ISSUE WAS QUESTIONED FOR THE CAUSE AND AFTER ATTEMPTING DIFFERENT SIZED SUCTION CATHETERS DOWN THE SIZE 6 TUBE, IT WAS DECIDED TO DO A BRONCHOSCOPY TO ASSESS THE CAUSE OF THE PROBLEM. THE PATIENT HAD TO BE RE-INTUBATED WITH A NEW TUBE AS A KINK WAS SEEN AT THE TIME OF THE SCOPE." ADDITIONAL INFORMATION RECEIVED 20-AUG-2019 NOTED THE INTUBATION WAS IN THE EMERGENCY DEPARTMENT AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) THAT DAY. THE DIFFICULTY SUCTIONING OCCURRED AT 0800HRS ON THE MORNING OF THE 07-AUG-2019. ADDITIONAL INFORMATION RECEIVED 21-AUG-2019 STATED THE PATIENT WAS ORIGINALLY INTUBATED AT 2000HRS ON 08-AUG-2019. THE ISSUE OF INABILITY TO PASS THE SUCTION CATHETER WAS FIRST NOTED AT 0800HRS ON 07-AUG-2019, NO CHANGES TO MV PARAMETERS WERE NOTED. A BRONCHOSCOPY WAS PERFORMED AT 1300HRS AND THE PATIENT WAS REINTUBATED WITH ANOTHER ENDOTRACHEAL TUBE (ETT) AT 1330HRS AT 07-

  Patient problems: Extubate

  MAUDE report 8989128 ↗