Ballard* Closed Suction System for Adults 98311Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00609038983110), received between Jun 18, 2021 and Jul 16, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED: THE INLINE SUCTION CATHETER WAS PLACED ON THE PATIENT WHILE ATTACHED TO THE VENTILATOR. [THE] PATIENT INDICATED SOMETHING WASN'T NORMAL WITH HIS BREATHING AND IT WAS NOTED THAT AIR WAS LEAVING OUT OF THE OPENING WHERE FLUSH/LAVAGE TUBING IS NORMALLY ATTACHED. [THE] PATIENT [WAS] GIVEN [A] NEW INLINE SUCTION [CATHETER]; THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22527447 ↗
• MalfunctionAug 10, 2023Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED, THAT WHEN ATTEMPTING TO ATTACH THE [IN-LINE SUCTION CATHETER] TO A FRESH TRACH TUBE, THE IN-LINE WOULD NOT CONNECT PROPERLY, AND A LEAK KEPT HAPPENING. AFTER EXAMINING THE IN-LINE, IT WAS FOUND THAT THE PLASTIC WAS THE WRONG SIZE NOT ALLOWING THE CATHETER TO ATTACH PROPERLY TO TRACHEOSTOMY TUBE. THERE WAS NO REPORTED INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17503495 ↗
• MalfunctionJan 10, 2023Inflation Problem; Inflation Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 8030647-2023-00003 FOR THE FIRST REPORT. IT WAS REPORTED THAT THE IN-LINE CATHETER WAS PLACED IN THE EVENING. THE NEXT DAY, IT INFLATED LIKE A BALLOON. NO INJURY OR MEDICAL INTERVENTIONS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 16134502 ↗
• MalfunctionJan 10, 2023Inflation Problem; Inflation Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 8030647-2023-00004 FOR THE SECOND REPORT. IT WAS REPORTED THAT THE IN-LINE CATHETER WAS PLACED IN THE MORNING. BY THE AFTERNOON, THE CATHETER INFLATED LIKE A BALLOON. NO INJURY OR MEDICAL INTERVENTIONS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 16134501 ↗
• MalfunctionOct 30, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED, "THE INSIDE PIECE OF PLASTIC (THAT ATTACHES TO THE TRACH) CAME UNATTACHED FROM THE OUTER PLASTIC PIECE (THAT SWIVELS). THE INNER PORTION WAS STUCK ON THE PATIENT'S TRACH, AND TOOK SOME EFFORT TO GET IT OFF." THERE WAS NOT REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 13-OCT-2021 STATES THE DEVICE WAS IN PLACE FOR LESS THAN A WEEK. THE DEVICE WAS NOT ALTERED FROM ITS ORIGINAL FORM. RESPIRATORY THERAPY EXTRACTED THE BROKEN PIECE FROM THE BIVONA TTS TRACH TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12725035 ↗
• MalfunctionJun 18, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE THUMB VALVE WAS STUCK IN THE DOWN POSITION RESULTING IN REDUCED VENTILATION TO THE PATIENT. THE VENTILATOR ALARMED AND NOTED A LOW CIRCUIT LEAK AND SHORTLY AFTER A LOW MINIMAL VENTILATION ALARM WAS TRIGGERED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12027230 ↗