Ballard* Closed Suction System 93825Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00609038938257), received between Feb 3, 2022 and Sep 15, 2026 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Break” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Break

  Patient problems: Low Oxygen Saturation

  MAUDE report 50781800 ↗
• 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 ↗
• InjuryFeb 14, 2023Material Integrity Problem; Material Integrity Problem

  ADDITIONAL INFORMATION RECEIVED 19JAN2023 REPORTED, MID-SHIFT ON (B)(6) 2023, THE REGISTERED NURSE (RN) FOUND THE PLASTIC SLEEVE TO THE CLOSED SUCTION CATHETER (CSC) ¿OPEN NEARLY END TO END¿. THEY WERE UNSURE IF IT HAD BEEN THAT WAY BEFORE AS THE TEAR WAS ONLY VISIBLE ON ONE SIDE; THE PATIENT HAD BEEN SUCTIONED AT LEAST HOURLY FOR MOST OF THE DAY; THE CSC HAD BEEN IN USE FOR POSSIBLY 5 DAYS. THE PATIENT WAS EVALUATED FOR SEPSIS, A TRACH ASPIRATE (TA) WAS PERFORMED AND FOUND TO HAVE GRAM POSITIVE COCCI FOR WHICH THE INFANT WAS STARTED ON ANTIBIOTICS. A CHEST X-RAY (CXR) REVEALED AREAS OF ATELECTASIS THAT MAY OR MAY NOT HAVE BEEN ASSOCIATED WITH A PNEUMONIA; A PERIPHERAL BLOOD CULTURE WAS POSITIVE FOR ENTEROCOCCUS FECALIS, (CONSIDERED AN ABSOLUTE PATHOGEN); ARTERIAL BLOOD WAS NEGATIVE FOR ANY MICROBES. IT WAS ADDITIONALLY REPORTED, THERE WAS NO WAY TO DEFINITIVELY ASSOCIATE POTENTIAL CENTRAL LINE-ASSOCIATED BLOODSTREAM INFECTION (CLABSI) WITH (TA) EXCEPT SAME GRAMS STAINED DESCRIPTION FOR ORGANISM. ADDITIONAL INFORMATION RECEIVED 06FEB2023 CLARIFIED, THE TA WAS NEGATIVE, PERFORMED ON (B)(6) 2023; THE BLOOD CULTURE WAS POSITIVE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacterial Infection

  MAUDE report 16375824 ↗
• MalfunctionJan 31, 2023Break; Break

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 8030647-2023-00011 FOR THE FIRST EVENT. IT WAS REPORTED "A BREAK IN THE PLASTIC SHEATH COVERING [THE] INLINE BALLARD SUCTION CATHETER RESULT[ED] IN LOSS OF VENTILATOR PRESSURE TO THE INFANT." THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 11-JAN-2023 STATED THE CLOSED SUCTION CATHETER (CSC) WAS IN USE "LESS THAN 3 DAYS" PRIOR TO THE REPORTED INCIDENT OCCURRING.

  Patient problems: Decreased Peak Expiratory Flow rate

  MAUDE report 16274672 ↗
• MalfunctionJan 31, 2023Break; Break

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 8030647-2023-00012 FOR THE SECOND EVENT. IT WAS REPORTED "A BREAK IN THE PLASTIC SHEATH COVERING [THE] INLINE BALLARD SUCTION CATHETER RESULT[ED] IN LOSS OF VENTILATOR PRESSURE TO THE INFANT." THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 11-JAN-2023 STATED THE CLOSED SUCTION CATHETER (CSC) WAS NOT ALTERED IN ANYWAY PRIOR TO THE REPORTED INCIDENT OCCURRING.

  Patient problems: Decreased Peak Expiratory Flow rate

  MAUDE report 16274666 ↗
• MalfunctionJun 20, 2022Break; Break

  IT WAS REPORTED, THE INFANT IN THE NEONATAL INTENSIVE CARE UNIT (NICU) WAS INTUBATED WITH THE 7FR IN-LINE SUCTION CATHETER, PART OF THE ADAPTER FOR THE SUCTION BROKE OFF AND BECAME STUCK IN THE INFANT¿S ENDOTRACHEAL TUBE; IT WAS REMOVED WITH A HEMOSTAT CLAMP. THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 02JUN2022 REPORTED THAT THE CATHETER WAS IN PLACE BETWEEN 12-24 HOURS [PRIOR TO THE EVENT]. THERE WAS NO REPORTED INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 14749402 ↗
• MalfunctionFeb 3, 2022Suction Failure; Suction Failure

  IT WAS REPORTED THE CLOSED SUCTION CATHETER WAS NOTED TO BE LEAKING AIR WHEN SUCTIONING. THE PATIENT EXPERIENCED DECREASED OXYGENATION AND HEART RATE LEADING TO FURTHER UNSPECIFIED MEDICAL INTERVENTIONS.

  Patient problems: Low Oxygen Saturation

  MAUDE report 13446415 ↗