Ballard* Closed Suction SystemRecalls & reported problems across all models
Avanos Medical, Inc. · 30 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Ballard* Closed Suction System model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 340
- Deaths reported
- 0
- Injuries reported
- 52
- Recalls
- 2
We found 30 models of Ballard* Closed Suction System by Avanos Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 340 adverse event reports in the FDA's MAUDE database, received between Jun 19, 2020 and Sep 29, 2026 — classified as 52 injuries, 288 malfunctions.
The most frequently reported specific device problem is “Break” (66 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 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 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, 2025Class IOpen, Classified
Lack of sterility assurance for closed suction catheter systems
Z-1522-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Mar 19, 2025Class IOpen, Classified
Lack of sterility assurance for closed suction catheter systems
Z-1521-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported Ballard* Closed Suction System problems
Device problems
- Break66
- Suction Problem57
- Material Integrity Problem55
- Suction Failure54
- Gas/Air Leak41
- Inflation Problem9
- Loose or Intermittent Connection9
- Material Puncture/Hole8
Patient problems
- No Clinical Signs, Symptoms or Conditions156
- Insufficient Information89
- Low Oxygen Saturation49
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available15
- Bacterial Infection8
- Decreased Peak Expiratory Flow rate5
- Discomfort5
- Foreign Body In Patient5
Ballard* Closed Suction System models
30 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Ballard* Closed Suction System 93826CATHETERS, SUCTION, TRACHEOBRONCHIAL1 recall70 reports
- Ballard* Closed Suction System 92431CATHETERS, SUCTION, TRACHEOBRONCHIAL78 reports
- Ballard* Closed Suction System 93834CATHETERS, SUCTION, TRACHEOBRONCHIAL1 recall2 reports
- Ballard* Closed Suction System 93833CATHETERS, SUCTION, TRACHEOBRONCHIAL29 reports
- Ballard* Closed Suction System 99430CATHETERS, SUCTION, TRACHEOBRONCHIAL25 reports
- Ballard* Closed Suction System 93824CATHETERS, SUCTION, TRACHEOBRONCHIAL24 reports
- Ballard* Closed Suction System 99426CATHETERS, SUCTION, TRACHEOBRONCHIAL19 reports
- Ballard* Closed Suction System 99409CATHETERS, SUCTION, TRACHEOBRONCHIAL17 reports
- Ballard* Closed Suction System 98383CATHETERS, SUCTION, TRACHEOBRONCHIAL14 reports
- Ballard* Closed Suction System 98386CATHETERS, SUCTION, TRACHEOBRONCHIAL9 reports
- Ballard* Closed Suction System 98384CATHETERS, SUCTION, TRACHEOBRONCHIAL8 reports
- Ballard* Closed Suction System 93825CATHETERS, SUCTION, TRACHEOBRONCHIAL7 reports
- Ballard* Closed Suction System 195-4JCATHETERS, SUCTION, TRACHEOBRONCHIAL7 reports
- Ballard* Closed Suction System 99331CATHETERS, SUCTION, TRACHEOBRONCHIAL4 reports
- Ballard* Closed Suction System 98385CATHETERS, SUCTION, TRACHEOBRONCHIAL3 reports
- Ballard* Closed Suction System 99420CATHETERS, SUCTION, TRACHEOBRONCHIAL3 reports
- Ballard* Closed Suction System 93827CATHETERS, SUCTION, TRACHEOBRONCHIAL2 reports
- Ballard* Closed Suction System 98298CATHETERS, SUCTION, TRACHEOBRONCHIAL2 reports
- Ballard* Closed Suction System 98388CATHETERS, SUCTION, TRACHEOBRONCHIAL2 reports
- Ballard* Closed Suction System 196-4JCATHETERS, SUCTION, TRACHEOBRONCHIAL2 reports
- Ballard* Closed Suction System 198-4JCATHETERS, SUCTION, TRACHEOBRONCHIAL2 reports
- Ballard* Closed Suction System 99335CATHETERS, SUCTION, TRACHEOBRONCHIAL2 reports
- Ballard* Closed Suction System 99434CATHETERS, SUCTION, TRACHEOBRONCHIAL2 reports
- Ballard* Closed Suction System 93823CATHETERS, SUCTION, TRACHEOBRONCHIAL1 report
- Ballard* Closed Suction System 93832CATHETERS, SUCTION, TRACHEOBRONCHIAL1 report
- Ballard* Closed Suction System 93895CATHETERS, SUCTION, TRACHEOBRONCHIAL1 report
- Ballard* Closed Suction System 93896CATHETERS, SUCTION, TRACHEOBRONCHIAL1 report
- Ballard* Closed Suction System 93902CATHETERS, SUCTION, TRACHEOBRONCHIAL1 report
- Ballard* Closed Suction System 98381CATHETERS, SUCTION, TRACHEOBRONCHIAL1 report
- Ballard* Closed Suction System 99569CATHETERS, SUCTION, TRACHEOBRONCHIAL1 report
Recent Ballard* Closed Suction System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Break
Patient problems: Insufficient Information
MAUDE report 50940511 ↗MalfunctionSep 29, 2026Break
Patient problems: Insufficient Information
MAUDE report 50940510 ↗MalfunctionSep 18, 2026Loose or Intermittent Connection
It was reported that hospital staff discovered the detached flapper valve one day after the Ballard device had been replaced. There was no reported delay in therapy, harm, or injury associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50819758 ↗MalfunctionSep 15, 2026Break
Patient problems: Low Oxygen Saturation
MAUDE report 50781800 ↗MalfunctionAug 11, 2026Break
It was reported that on the third day of use of the TracheCare 72, hospital staff observed that the flapper valve had detached from the catheter mount side. The detached flapper valve was not found inside the tracheal tube, and no adverse health effects occurred. An additional flapper valve was found at the bedside and was presumed to have also detached.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50211821 ↗MalfunctionJul 17, 2026Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25864644 ↗MalfunctionApr 30, 2026Loose or Intermittent Connection
IT WAS REPORTED THAT DURING PATIENT USE, REPEATED DETACHMENT OF THE IRRIGATION PORT WAS OBSERVED. NO HARM OR INJURY WAS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25050130 ↗MalfunctionApr 3, 2026Break
IT WAS REPORTED THAT THE PATIENT HAD JUST COMPLETED CARE, AND THE MOTHER REQUESTED TO HOLD THE INFANT. THE RT AND NURSE PREPARED TO TRANSFER THE PATIENT WITH THE MOTHER TO A CHAIR. DURING THE PREPARATION, THE RT NOTED A LEAK; THE MOTHER AND GRANDMOTHER STATED THEY HAD HEARD A SIMILAR SOUND ON PREVIOUS DAYS, BUT THAT NO ISSUE HAD BEEN IDENTIFIED. THE PATIENT WAS TRANSFERRED SAFELY WITH THE MOTHER TO THE CHAIR, AT WHICH TIME THE LEAK BECAME LOUDER. AFTER SECURING THE PATIENT AND VENTILATOR TUBING TO THE MOTHER AND CHAIR, THE RT IDENTIFIED THAT THE Y CONNECTOR CONNECTING THE VENTILATOR TUBING AND SUCTION BALLARD TO THE ETT WAS COMPLETELY BROKEN, WITH A PORTION LODGED IN THE PROXIMAL END OF THE ETT. THE PATIENT REMAINED STABLE THROUGHOUT THE EVENT. THE RT MANUALLY STABILIZED THE BROKEN COMPONENTS AND NOTIFIED THE PRACTITIONER, WHO ARRIVED PROMPTLY. THE RT SECURELY HELD THE ETT WHILE THE PRACTITIONER USED MEDICAL FORCEPS TO SAFELY REMOVE THE BROKEN PIECE. THE PATIENT TOLERATED THE PROCEDURE WELL AND REMAINED STABLE THROUGHOUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24779338 ↗MalfunctionMar 19, 2026Inflation Problem; Gas/Air Leak; Infusion or Flow Problem
IT WAS REPORTED, THE NEW IN-LINE SUCTION CATHETER (CSC) WAS ATTACHED TO THE ENDOTRACHEAL TUBE (ETT). IT WAS NOTED THAT UPON THE SECOND USE OF THE CSC IT HAD FILLED WITH AIR, THE VENTILATOR ALARMED HIGH LEAK, AND THE PATIENT DESATURATED. THE PORT WAS TURNED ON AND OFF, THE CSC WAS REMOVED AND THE DEVICE WAS REPLACED. THERE WAS NO REPORTED INJURY.
Patient problems: Low Oxygen Saturation
MAUDE report 24645111 ↗MalfunctionNov 13, 2025Break; Connection Problem; Break; Connection Problem
IT WAS REPORTED WHILE USING THE TRUCK CARE SYSTEM, NP DISCOVERED THAT THE FLAP VALVE HAD COME LOOSE AND FALLEN INTO THE CIRCUIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23550863 ↗MalfunctionNov 13, 2025Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE FLAPPER VALVE DETACHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23550860 ↗MalfunctionNov 13, 2025Break; Break
SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 8030647-2025-00126 FOR THE SECOND REPORT. IT WAS REPORTED, THE FLAPPER VALVE DETACHED DURING USE; THERE WAS NO REPORT OF A DELAY IN THERAPY AND/OR HARM OR INJURY AS A RESULT OF THIS REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23550254 ↗MalfunctionNov 13, 2025Break; Break
SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 8030647-2025-00125 FOR THE FIRST REPORT. IT WAS REPORTED, THE FLAPPER VALVE DETACHED DURING USE; THERE WAS NO REPORT OF A DELAY IN THERAPY AND/OR HARM OR INJURY AS A RESULT OF THIS REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23550253 ↗MalfunctionNov 7, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED: UNABLE TO THREAD THE CATHETER THROUGH AND IT BECAME STUCK IN THE HUB (IT WAS FOUND TO BE BENT); IT DID EVENTUALLY GO THROUGH, WITH FORCE. THE CATHETER WAS REPLACED. IT WAS ADDITIONALLY REPORTED, THE EXTREMELY PRE-TERM INFANT DESATURATED WHILE THE DEVICE WAS UNABLE TO SUCTION; IT WAS NOTED THERE WAS NO CHANGE TO THE CLINICAL CONDITION OF THE INFANT.
Patient problems: Low Oxygen Saturation
MAUDE report 23501749 ↗MalfunctionNov 5, 2025Material Puncture/Hole; Material Puncture/Hole
SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 8030647-2025-00121 FOR THE SECOND REPORT IT WAS REPORTED: WHEN INSERTING AN 8FR BALLARD CLOSED-CIRCUIT CATHETER, IT WAS DETECTED THAT IT WAS PIERCED, MAKING IT IMPOSSIBLE TO USE ON THE PATIENT. THERE WAS NO REPORTED INJURY AS A RESULT OF THIS REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23482421 ↗
Other Avanos Medical, Inc. products
- Halyard232 models · 1,210 reports · 1 recall
- Ballard* Turbo-Cleaning Closed Suction System16 models · 123 reports · 3 recalls
- Ballard* Closed Suction System for Adults17 models · 121 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-FLOW2 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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