Ballard* Closed Suction System for Adults 92467Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00609038924670), received between Jul 1, 2021 and Mar 4, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionMar 4, 2022Break; Break

  IT WAS REPORTED DURING INITIAL USE THE "AIRWAY CONNECTION [WAS] SNAPPING OFF IN HALF AT STEM." THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 13668078 ↗
• InjuryNov 12, 2021Increase in Suction; Physical Resistance/Sticking; Increase in Suction; Physical Resistance/Sticking

  PER ADDITIONAL INFORMATION RECEIVED 10 NOV 2021, THE CATHETER WAS REPLACED WITH A NEW ONE. "THE PATIENT WAS OK ONCE THE CATHETER HAD BEEN REPLACED."

  Patient problems: Decreased Peak Expiratory Flow rate

  MAUDE report 12803904 ↗
• InjuryJul 1, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT SOMEONE TAKING CARE OF A PATIENT ON A VENTILATOR THOUGHT THE DOUBLE SWIVEL ELBOW WAS A T-PIECE CONFIGURATION AND WHILE TRYING TO WEAN THE PATIENT OFF THE VENTILATOR, THE PATIENT "SUFFOCATED." NO FURTHER DETAILS WERE PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: Respiratory Insufficiency

  MAUDE report 12101786 ↗