Ballard* Closed Suction System for Adults 98312Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00609038983127), received between Jun 19, 2023 and Jan 30, 2025 — classified as 4 malfunctions.

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

• MalfunctionJan 30, 2025Decrease in Suction; Suction Problem; Decrease in Suction; Suction Problem

  IT WAS REPORTED, THE CONDENSATION WAS INCREASED IN THE AIRWAY CIRCUIT PROBE, WITH LOW SUCTION FORCE THE CLOSED SUCTION SYSTEM DID NOT ACHIEVE ADEQUATE BRONCHIAL SWEEP AND REQUIRED MORE THAN 10 ASPIRATIONS TO MOBILIZE SECRETIONS. THE DEVICE WAS REPORTED TO HAVE BEEN IN PLACE FOR LESS THAN 20 HOURS. THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 21277146 ↗
• MalfunctionOct 15, 2024Break; Break

  IT WAS REPORTED, THE ENDOTRACHEAL TUBE (ETT) BROKE AT THE INLET OF THE PROBE WHICH CAUSED A CIRCUIT LEAK DURING PATIENT USE (THE DEVICE HAD BEEN IN USE FOR LESS THAN 20 HOURS); THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 18SEP2024 REPORTED, THE PATIENT DID NOT PRESENT ANY COMPLICATION ABOUT THE USE OF THE MEDICAL DEVICE, BUT APPROXIMATELY 10 DAYS AFTER THE INCIDENT THE PATIENT DIED FROM A SEVERE ABDOMINAL SEPSIS. NO ADDITIONAL INFORMATION WAS PROVIDED CONCERNING THE PATIENT OR IF THEY HAD ANY EXISTING MEDICAL CONDITION(S).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20450510 ↗
• MalfunctionFeb 12, 2024Decoupling; Decoupling

  IT WAS REPORTED, THE RESPIRATORY THERAPIST PERFORMED A ROUTINE CHANGE OF THE CLOSED SUCTION SYSTEM ON A TRACHEOSTOMIZED PATIENT, AT THE MOMENT OF CONNECTING THE VIAL FOR INSTILLATION IN ITS CORRESPONDING PORT, IT DETACHED AND UNCOUPLED UNTIL THE INTERNAL SPRING WAS OBSERVED. IT WAS IMMEDIATELY CHANGED, ¿THERE WAS NO DAMAGE OR CLINICAL OR HEMODYNAMIC ALTERATION TO THE PATIENT." THE DEVICE WAS REPORTEDLY IN PLACE FOR LESS THAN 20 HOURS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18687824 ↗
• MalfunctionJun 19, 2023Suction Problem; Suction Problem

  ADDITIONAL INFORMATION NOTED SUCTION FAILURE OCCURRED DURING INITIAL SET-UP USE AND WAS REPLACED IMMEDIATELY.

  Patient problems: Insufficient Information

  MAUDE report 17159520 ↗