Ballard* Closed Suction System for AdultsRecalls & reported problems across all models
Avanos Medical, Inc. · 17 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
3 open recalls name at least one Ballard* Closed Suction System for Adults model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 121
- Deaths reported
- 1
- Injuries reported
- 8
- Recalls
- 3
We found 17 models of Ballard* Closed Suction System for Adults by Avanos Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 121 adverse event reports in the FDA's MAUDE database, received between Jul 20, 2020 and Apr 2, 2026 — classified as 1 death, 8 injuries, 112 malfunctions.
The most frequently reported specific device problem is “Suction Failure” (47 reports).
3 FDA recall records name at least one of these models by its device identifier, 3 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Ballard* Closed Suction System for Adults recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Mar 19, 2025Open, Classified
Lack of sterility assurance for closed suction catheter systems
Z-1525-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Mar 19, 2025Open, Classified
Lack of sterility assurance for closed suction catheter systems
Z-1524-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Oct 13, 2023Open, Classified
Certain lots of BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI were labeled as not being made with Di(2-ethylhexyl) phthalate (DEHP); however, Avanos has determined that the tubing components of the product did contain DEHP.
Z-0360-2024 · Root cause: Labeling Change Control · Recall details · FDA record ↗
Most reported Ballard* Closed Suction System for Adults problems
Device problems
- Suction Failure47
- Suction Problem29
- Break7
- Disconnection5
- Gas/Air Leak5
- Inflation Problem4
- Infusion or Flow Problem3
- Loose or Intermittent Connection3
Patient problems
- Insufficient Information60
- No Clinical Signs, Symptoms or Conditions46
- Low Oxygen Saturation7
- No Consequences Or Impact To Patient4
- Airway Obstruction2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Asphyxia1
- Chest Pain1
Ballard* Closed Suction System for Adults models
17 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Ballard* Closed Suction System for Adults 98310CATHETERS, SUCTION, TRACHEOBRONCHIAL1 recall1 death9 reports
- Ballard* Closed Suction System for Adults 94492CATHETERS, SUCTION, TRACHEOBRONCHIAL1 recall3 reports
- Ballard* Closed Suction System for Adults 94506CATHETERS, SUCTION, TRACHEOBRONCHIAL1 recall0 reports
- Ballard* Closed Suction System for Adults 93906CATHETERS, SUCTION, TRACHEOBRONCHIAL32 reports
- Ballard* Closed Suction System for Adults 93907CATHETERS, SUCTION, TRACHEOBRONCHIAL29 reports
- Ballard* Closed Suction System for Adults 93905CATHETERS, SUCTION, TRACHEOBRONCHIAL11 reports
- Ballard* Closed Suction System for Adults 98297CATHETERS, SUCTION, TRACHEOBRONCHIAL8 reports
- Ballard* Closed Suction System for Adults 98311CATHETERS, SUCTION, TRACHEOBRONCHIAL6 reports
- Ballard* Closed Suction System for Adults 98316CATHETERS, SUCTION, TRACHEOBRONCHIAL6 reports
- Ballard* Closed Suction System for Adults 98312CATHETERS, SUCTION, TRACHEOBRONCHIAL4 reports
- Ballard* Closed Suction System for Adults 92467CATHETERS, SUCTION, TRACHEOBRONCHIAL3 reports
- Ballard* Closed Suction System for Adults 99351CATHETERS, SUCTION, TRACHEOBRONCHIAL3 reports
- Ballard* Closed Suction System for Adults 98268CATHETERS, SUCTION, TRACHEOBRONCHIAL2 reports
- Ballard* Closed Suction System for Adults 98295CATHETERS, SUCTION, TRACHEOBRONCHIAL2 reports
- Ballard* Closed Suction System for Adults 92470CATHETERS, SUCTION, TRACHEOBRONCHIAL1 report
- Ballard* Closed Suction System for Adults 98951CATHETERS, SUCTION, TRACHEOBRONCHIAL1 report
- Ballard* Closed Suction System for Adults 99376CATHETERS, SUCTION, TRACHEOBRONCHIAL1 report
Recent Ballard* Closed Suction System for Adults adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 2, 2026Mechanical Problem
IT WAS REPORTED THAT THE INHALATION PORT IS HARD AND STIFF AND DETACHES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24772291 ↗MalfunctionMar 18, 2026
INLINE SUCTION BALLARD HAD A HOLE WITH A SMALL LEAK. FOUND WHEN TURNING PATIENT'S HEAD TO RIGHT. BALLARD WAS QUICKLY CHANGED TO NEW BALLARD SAFELY. NO PT HARM WAS REPORTED. SIMILAR ISSUE WAS REPORTED FOR ANOTHER PATIENT AS WELL. THIS SPECIFIC LOT WAS SEQUESTERED AND TAKEN OUT OF USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24625919 ↗MalfunctionMar 18, 2026
INLINE SUCTION BALLARD HAD A HOLE WITH A SMALL LEAK. FOUND WHEN TURNING PATIENT'S HEAD TO RIGHT. BALLARD WAS QUICKLY CHANGED TO NEW BALLARD SAFELY. NO PT HARM WAS REPORTED. SIMILAR ISSUE WAS REPORTED FOR ANOTHER PATIENT AS WELL. THIS SPECIFIC LOT WAS SEQUESTERED AND TAKEN OUT OF USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24625903 ↗InjuryOct 29, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED, DURING SUCTIONING, THE CATHETER CURVED AND SCRAPED AGAINST THE TRACHEAL WALL OF THE PATIENT AND CAUSED BLEEDING; NO MEDICAL INTERVENTION WAS REPORTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23420567 ↗MalfunctionSep 25, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
THE HOME CARE NURSE REPORTED, THE BALLARD CLOSED SUCTION SYSTEM, KEPT FILLING WITH AIR; THERE WAS NO REPORTED INJURY.
Patient problems: Insufficient Information
MAUDE report 23151428 ↗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 ↗MalfunctionJul 10, 2025Infusion or Flow Problem; Infusion or Flow Problem
SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE FIRST OF TWO REPORTS. REFER TO 8030647-2025-00067 FOR THE SECOND REPORT. IT WAS REPORTED, WHEN THE REGISTERED NURSE ATTEMPTED TO FLUSH THE CATHETER AFTER SUCTIONING THE FLUSH FLUID WENT INTO THE CLEAR PROTECTIVE SLEEVE INSTEAD OF THE CATHETER; THERE WAS NO REPORTED INJURY. THE CATHETER WAS REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22469275 ↗MalfunctionJul 10, 2025Infusion or Flow Problem; Infusion or Flow Problem
SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF TWO REPORTS. REFER TO 8030647-2025-00066 FOR THE FIRST REPORT. IT WAS REPORTED, WHEN THE REGISTERED NURSE ATTEMPTED TO FLUSH THE CATHETER AFTER SUCTIONING THE FLUSH FLUID WENT INTO THE CLEAR PROTECTIVE SLEEVE INSTEAD OF THE CATHETER; THERE WAS NO REPORTED INJURY. THE CATHETER WAS REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22469274 ↗MalfunctionJun 20, 2025Break; Break
IT WAS REPORTED, THE ELBOW BROKE OFF DURING USE. THERE WAS NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22302991 ↗MalfunctionMay 23, 2025Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED, THE SLEEVE DID NOT INFLATE; THERE WAS NO REPORTED INJURY TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22081832 ↗MalfunctionMay 13, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED, THE LEAK ALARM SOUNDED DURING THE ROUND CHECK AND THE STAFF REPLACED [THE] ANESTHESIA CIRCUIT. AFTER REPLACEMENT THE LEAK ALARM CONTINUED AND THE STAFF REPLACED THE ENDOTRACHEAL TUBE (ETT) AFTER WHICH THE ALARM SILENCED. THERE WAS NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22013646 ↗MalfunctionMar 20, 2025
CONNECTED NEW BALLARD TO PATIENT'S TRACH (SWITCHED FROM A SMALLER SIZE); 1 HOUR LATER, ATTEMPTED TO SUCTION PATIENT AND NO SECRETIONS ABLE TO BE SUCTIONED. CHECKED SUCTION TUBING WHICH WAS WORKING. ATTEMPTED TO SUCTION AGAIN UNSUCCESSFULLY. DISCONNECTED BALLARD FROM PATIENT AND NOTICED NOT ABLE TO SUCTION. CHANGED TO A NEW BALLARD AGAIN AND SUCCESSFULLY SUCTIONED THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21651106 ↗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 ↗MalfunctionDec 31, 2024Suction Failure; Suction Failure
SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF TWO REPORTS. REFER TO 8030647-2024-00108 FOR THE FIRST REPORT. IT WAS REPORTED, THE SUCTION CATHETER FAILED DURING THE PROCEDURE; THE CATHETER WAS REPLACED; THERE WAS NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21048619 ↗MalfunctionDec 31, 2024Suction Failure; Suction Failure
SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE FIRST OF TWO REPORTS. REFER TO 8030647-2024-00109 FOR THE SECOND REPORT . IT WAS REPORTED, THE SUCTION CATHETER FAILED DURING THE PROCEDURE; THE CATHETER WAS REPLACED; THERE WAS NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21048618 ↗
Other Avanos Medical, Inc. products
- Halyard232 models · 1,210 reports · 1 recall
- Ballard* Closed Suction System30 models · 340 reports · 2 recalls
- Ballard* Turbo-Cleaning Closed Suction System16 models · 123 reports · 3 recalls
- CORTRAK* 2 Enteral Access System2 models · 134 reports · 1 recall
- Cortrak 2 Enternal access device14 models · 164 reports
- NEOMED*24 models · 0 reports · 3 recalls
- Microcuff* Endotracheal Tube for Adults8 models · 102 reports
- ON-Q* Pain Relief System with SELECT-A-FLOW*2 models · 94 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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