Ballard* Closed Suction System 93827Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00609038938271), received between Oct 30, 2021 and Dec 10, 2024 — classified as 2 malfunctions.

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. How this data works · Data updated Oct 13, 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 10, 2024Material Integrity Problem; Material Twisted/Bent; Material Integrity Problem; Material Twisted/Bent

  IT WAS REPORTED THAT THE TIP OF THE INLINE SUCTION CATHETER WAS BENT, AFFECTED THE PRESSURES ON THE VENTILATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20897831 ↗
• MalfunctionOct 30, 2021Break; Break

  IT WAS REPORTED, "THE TIP END OF THE SUCTION CATHETER BROKE OFF AND WAS NOTICED IN THE PART OF THE ADAPTOR THAT ATTACHES TO THE ENDOTRACHEAL TUBE. THE CLINICIAN WAS UNAWARE IT CAME OFF, BUT SEEN THE BLACK BAND AND DISCONNECTED THE BALLARD TO RETRIEVE THE OBJECT AND THEN REALIZED IT WAS THE TIP OF THE SUCTION TUBE." THE BROKEN PART WAS NOT IN THE PATIENT'S ENDOTRACHEAL TUBE NOR THE PATIENT'S LUNG(S). ADDITIONAL INFORMATION RECEIVED ON 14-OCT-2021 STATED THE DEVICE WAS NOT ALTERED. THE PATIENT WAS DOING WELL. THE PATIENT REMAINS ON THE JET VENTILATOR AT 21% FIO2 AT THE TIME OF THIS INFORMATION. INFANT DID NOT REQUIRE RE-INTUBATION SINCE THE PIECE WAS IN PART OF THE ENDOTRACHEAL TUBE ADAPTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12725064 ↗