Ballard* Closed Suction System 98383Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00609038983837), received between Feb 24, 2021 and Nov 7, 2025 — classified as 3 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (3 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionOct 29, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  EVENT DESCRIPTION (FDA B5): 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 8030647-2025-00113 FOR THE SECOND REPORT. IT WAS REPORTED: THE INLINE SUCTION DEVICE COULD NOT PASS THROUGH THE OPENING OF THE CONNECTOR, DISCOVERED DURING USE ON A VENTILATED INFANT. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23420516 ↗
• MalfunctionOct 29, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  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 8030647-2025-00112 FOR THE FIRST REPORT. IT WAS REPORTED: THE INLINE SUCTION DEVICE COULD NOT PASS THROUGH THE OPENING OF THE CONNECTOR, DISCOVERED DURING USE ON A VENTILATED INFANT. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23420515 ↗
• MalfunctionJul 15, 2025Break; Break

  IT WAS REPORTED, THE INLINE SUCTION CATHETER BROKE (THE TWIST ON/OFF KNOB BROKE); THERE WAS NO REPORTED INJURY TO THE PATIENT WHO DID NOT REQUIRE FREQUENT SUCTIONING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22514759 ↗
• InjuryJul 10, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED, THE CATHETER COULD NOT BE PASSED THROUGH THE END TIP AS THE HOLE WAS TOO NARROW FOR THE CATHETER. THE PATIENT WHO WAS UNSTABLE AT THE TIME, REMAINED ON VENTILATION AS A NEW ATTEMPT WAS MADE WITH A DIFFERENT CLOSED SUCTION CATHETER (CSC). THE QUICK ACTIONS OF THE STAFF ENABLED THE PATIENT TO BE SUCCESSFULLY SUCTIONED AFTER WHICH THE PATIENT FELT BETTER. THE PATIENT'S HOSPITAL STAY WAS EXTENDED. NO ADDITIONAL INFORMATION WAS PROVIDED CONCERNING THE PATIENT'S CONDITION AND CARE.

  Patient problems: Insufficient Information

  MAUDE report 22472425 ↗
• MalfunctionFeb 11, 2025Suction Problem; Suction Problem

  IT WAS REPORTED; THE CHILD'S CLOSED SUCTION SYSTEM (CSC) WAS CHANGED EVERY MORNING BY IDE. AN ATTEMPT TO FLUSH SALINE THROUGH THE ORIFICE PROVIDED FOR THIS PURPOSE ON THE CLOSED SYSTEM WAS MADE; HOWEVER, THE SUCTION PROBE WAS BLOCKED AT THE Y [CONNECTOR] AND IT WAS IMPOSSIBLE TO SUCTION THE CHILD WHO DESATURATED. THE DECISION TO DECODE AND TO ASPIRATE DIRECTLY INTO THE TRACHEA WITH A STANDARD SUCTION TUBE WAS MADE. THE CSC WAS REPLACED AND THERE WERE NO ADDITIONAL PROBLEMS AFTER THAT.

  Patient problems: Low Oxygen Saturation

  MAUDE report 21360545 ↗
• MalfunctionDec 23, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED, THE HOLE IN THE CLOSED SYSTEM WAS BLOCKED AND DID NOT ALLOW THE SUCTION SENSOR TO PASS THROUGH THE Y-FITTING. THE DEVICE THEREFORE HAD TO BE CHANGED TO ACHIEVE SUCTION. THERE WERE NO CLINICAL CONSEQUENCES FOR THE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21008070 ↗
• MalfunctionDec 6, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED; THE CLOSED SUCTION CATHETER DID NOT ADVANCE; THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 20864961 ↗
• MalfunctionFeb 29, 2024Suction Failure; Suction Failure

  THE PHARMACIST REPORTED, ALTHOUGH THE DEVICE WAS CORRECTLY PLACED, IT DID NOT ASPIRE; THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18812940 ↗
• MalfunctionFeb 12, 2024Increase in Suction; Material Twisted/Bent; Increase in Suction; Material Twisted/Bent

  IT WAS REPORTED, THE CATHETER WAS BAD (THE END OF THE TIP WAS CROOKED) AND SOMETIMES IMPOSSIBLE TO MOVE. IT WAS ADDITIONALLY REPORTED, THE PATIENT EXPERIENCED AN INTERRUPTION OF VENTILATION (AS THEY WERE UNABLE TO SUCTION QUICKLY) AND EXPERIENCED LOW SATURATION RATES "FOR LONGER"; A NEW SYSTEM HAD TO BE OBTAINED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 18687817 ↗
• MalfunctionNov 8, 2022Suction Failure; Suction Failure

  IT WAS REPORTED THAT THE CLOSED SUCTION CATHETER WAS CONNECTED AND DID NOT SUCTION. ONCE IT WAS REALIZED, THE CLOSED SUCTION CATHETER WAS REMOVED. THE REPORTER ATTEMPTED TO SUCTION STERILE WATER AND CONFIRMED IT WOULD NOT SUCTION. THE PATIENT WAS REPORTED TO BE IN NEONATAL INTENSIVE CARE UNIT (NICU). PER ADDITIONAL INFORMATION RECEIVED ON 2022-OCT-26, NO NEGATIVE CONSEQUENCES OCCURRED AS A RESULT OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15756087 ↗
• MalfunctionJul 6, 2022Suction Failure; Suction Failure

  IT WAS REPORTED THAT AFTER CONNECTING THE SUCTION SET TO THE ENDOTRACHEAL CANNULA, IT WAS NOT POSSIBLE TO ASPIRATE MUCUS FROM THE ENDOTRACHEAL CANNULA. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14929671 ↗
• InjuryJun 21, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED 'DURING TRACHEAL ASPIRATION OF THE CHILD WITH A CLOSED SYSTEM, (ASPIRATION PROBE IN THE PROCESS OF DESCENT INTO THE INTUBATION TUBE), THE PLASTIC PART SURROUNDING THE TUBE BEGAN TO SWELL AND THE CHILD TO BRADYCARDIA AND DESATURATE.' ADDITIONAL INFORMATION RECEIVED 01-JUN-2022 STATED THE PATIENT WAS 5-DAYS POST-OP FOR DUCTUS ARTERIOSUS SURGERY, VENTILATED IN CPAP WITH CAFFEINE DOPRAM SUPPORT. THE PATIENT WAS PARENTERALLY AND ENTERALLY FED. THE PATIENT STILL HAS NUMEROUS EPISODES OF BRADYCARDIA. ADDITIONAL INFORMATION RECEIVED 10-JUN-2022 STATED AT THE TIME OF THE EVENT THE CAREGIVER PERFORMING ASPIRATION MANAGED THE DESTABILIZATION OF THE PATIENT. THE SUCTION CATHETER WAS REPLACED WITH A NEW ONE THAT DID NOT CAUSE ANY PROBLEMS IN USE. ADDITIONALLY, IT WAS NOTED SURGERY, VENTILATION, AND DIET WERE PART OF THE PATIENT'S HEALTH CONDITION BUT THE PROLONGED BRADYCARDIA WAS DUE TO THE USE OF THE CATHETER.

  Patient problems: Bradycardia; Low Oxygen Saturation

  MAUDE report 14760384 ↗
• InjuryFeb 24, 2021Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  IT WAS REPORTED THAT THE CLEAR PLASTIC SHEATH OF THE SUCTION CATHETER WAS INFLATED. THE PATIENT HAD JUST HAD INLINE SUCTION PERFORMED. THE VENTILATOR BEGAN ALARMING AND SWITCHED TO BACKUP MODE; THE APNEA ALARM WAS ALSO SHOWING. NO CHEST MOVEMENT WAS SEEN. PATIENT WAS CLINICALLY STABLE ON MANUAL VENTILATION VIA NEOPUFF. USER FACILITY REPORTED "CONTINUED MANUAL VENTILATION IN BETWEEN TRIALS OF GETTING BACK ONTO THE VENTILATOR, [PATIENT] REMAINED WELL." ADDITIONAL INFORMATION RECEIVED FROM THE USER FACILITY ON 04-FEB-2021 INDICATED "AFTER FURTHER INVESTIGATION BY OUR UNIT, IT WAS DISCOVERED THAT THIS PROBLEM WAS NOT A MANUFACTURING FAULT AND FURTHER TRAINING WILL BE GIVEN TO STAFF. THANK YOU FOR YOUR HELP WITH THIS AND APOLOGIZE FOR THE INCONVENIENCE THIS HAS CAUSED."

  Patient problems: Apnea

  MAUDE report 11372561 ↗