Halyard 13223Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10680651132236), received between Jul 20, 2017 and Dec 31, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 31, 2020Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE HAD A CUFF LEAK. THE TUBE WAS REPLACED FOR A NEW ONE AFTER TWO DAYS OF USE. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION RECEIVED 23-DEC-2020 INDICATED THE EVENT WAS DISCOVERED DURING A PILOT BALLOON CHECK. THE PRODUCT WAS USED FOR TWO DAYS "WITHOUT NOTIFYING THE PROBLEM. USED PRESSURE IS UNKNOWN."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11102581 ↗
• MalfunctionNov 9, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THE MICROCUFF BURST DURING USE. THERE WAS NO REPORTED PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED 25-OCT-2018 STATED LEAKING OCCURRED AFTER 2-HOURS AFTER INTUBATION. ALL THE PROTOCOLS WERE FOLLOWED AND PRECAUTIONS WERE TAKEN WHILE INTUBATING THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8056710 ↗
• MalfunctionMar 21, 2018Disconnection; Disconnection

  IT WAS REPORTED THAT "A PATIENT WAS INTUBATED WITH AN 8.0 MICROCUFF THAT KEPT COMING APART WHERE THE TUBE CONNECTS TO THE BLUE CONNECTOR AND THEN TO THE VENTILATOR CIRCUIT. THE END OF THE SUBGLOTTIC MICROCUFF ENDOTRACHEAL TUBE (ET) BECAME STRETCHED OUT. INITIALLY THE STAFF PULLED ANOTHER 8.5 CONNECTOR FROM ANOTHER NEW TUBE TO IMPROVE THE FIT, BUT THAT SOLUTION FAILED. ULTIMATELY THE ANESTHESIOLOGIST USED A SUTURE THREAD TO WRAP AROUND THE END OF THE ET TUBE AND TIED A KNOT TO THE BLUE CONNECTOR. NO HARM TO THE PATIENT AS A RESULT. "

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7359280 ↗
• MalfunctionJul 20, 2017Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE ADAPTER DISCONNECTS TOO EASILY, RESULTING IN A DISCONNECTION OF THE PATIENT FROM THE VENTILATOR. THIS HAPPENS FREQUENTLY AFTER USING AN AMBU BAG ON THE ADAPTER. PER ADDITIONAL INFORMATION WAS RECEIVED ON 29-JUN-2017, THERE WAS NO PATIENT INJURY AND NO MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION WAS PROVIDED AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6728759 ↗