Halyard 35115Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10680651351156), received between Jun 27, 2018 and May 27, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Air Leak” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT WHEN INSERTING THE TUBE FOR THE BRAIN SURGERY THAT AIR VENTILATION WAS NOT ENOUGH, DUE TO THE TUBE BEING BLOCKED. THE TUBE WAS REMOVED AND FOUND TO BE BENT; A NEW TUBE WAS PLACED. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14529553 ↗
• MalfunctionJul 29, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT "INVASIVELY VENTILATED PT [PATIENT] WAS NOTICED TO BE DESATURATING (PAEDIATRIC) AND INCREASING ETCO2 POST INTUBATION IN ED [EMERGENCY DEPARTMENT] (APPROXIMATELY 4 HOURS POST-INTUBATION). TUBE WAS CHECKED FOR PATENCY AND, VIA SUCTION CATHETER, NOTED HARD TO GET ACCESS. TUBE WAS REMOVED, KINK NOTED AND PATIENT RE-TUBED." NO PATIENT INJURY WAS REPORTED; HOWEVER, MEDICAL INTERVENTION WAS PERFORMED. PATIENT RE-TUBED PRIOR TO BEING FLOWN TO ANOTHER HOSPITAL. ADDITIONAL INFORMATION RECEIVED 11-JUL-2019 INDICATED THAT THE "INTUBATION WAS A STRAIGHT FORWARD GRADE 1 INTUBATION WITHOUT ANY COMPLICATIONS. I USED A MAC 2 BLADE ON THE CMAC IN ED. I DID NOT USE A BOUGIE OR STYLET AT ANY TIME DURING THE INTUBATION. THE ETT [ENDOTRACHEAL TUBE] WAS SECURED USING A TUBE TIE AND POSITION CONFIRMED WITH CAPNOGRAPHY. TUBE WAS 15CM AT THE LIPS AFTER BEING SECURED. NO ISSUES VENTILATING THE CHILD AFTER THE INITIAL INTUBATION."

  Patient problems: Hypoxia

  MAUDE report 8837913 ↗
• MalfunctionJun 27, 2018Air Leak; Air Leak

  IT WAS REPORTED THAT THE CUFF PRESSURE DROPPED OVER TIME. THE CUFF REQUIRED RE-INFLATION SEVERAL TIMES EACH SHIFT. THE HOSPITAL IS USING NEW VENTILATOR MACHINES THAT ALARM WHEN AN AIR LEAK IS DETECTED. PER ADDITIONAL INFORMATION RECEIVED (B)(6) 2018, THE NURSE REPORTS THE RISK OF INJURY TO PATIENTS IS LOW, AS THE VENTILATOR ALARM ENSURES THAT THE NURSES KNOW WHEN TO RE-INFLATE THE CUFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7641193 ↗