Ballard* Closed Suction System for Adults 98310Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00609038983103), received between Jul 31, 2020 and Jul 10, 2025 — classified as 1 death, 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Disconnection” (3 reports).

1 FDA recall record name this device's identifier, 1 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, 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.

Recalls naming this device

1. Mar 19, 2025Class IOpen, Classified

   Lack of sterility assurance for closed suction catheter systems

   Z-1525-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryAug 14, 2024Increase in Suction; Increase in Suction

  IT WAS REPORTED, THE SUCTION BUTTON [WAS] STUCK IN ACTIVE SUCTION MODE, AFFECTING VENTILATOR VOLUMES DELIVERED TO THE PATIENT. VOLUME LOSS MEASURED TO BE ABOUT 300ML. TRIED DEPRESSING BUTTON AND EVEN TURNING KNOB 45 DEGREES AND COULD NOT INACTIVATE SUCTION. [THE] CATHETER [WAS] CHANGED OUT. IT WAS ADDITIONALLY REPORTED, PATIENT INJURY, "¿NOT SURE."

  Patient problems: Low Oxygen Saturation

  MAUDE report 19986894 ↗
• MalfunctionSep 18, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED, THERE WAS A LARGE DISCREPANCY BETWEEN SET VENTILATION (VT) AND EXHALED VT (450 ML VS. 200 ML). THE INLINE SUCTION WAS CHANGED AND THE VOLUME LOSS RESOLVED AND THE SET VT WAS EQUAL TO EXHALED VT. THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 30AUG2023 REPORTED, THE ADULT PATIENT DISPLAYED A LARGE LEAK WITH VENTILATOR VOLUMES SET AT 450MLS AND MEASURED BACK AT 280-350MLS. THE PATIENT WAS UPSIZED TO AN 8.0 BREATHING TUBE; HOWEVER, A LEAK WAS STILL NOTICED. THE RESPIRATORY [THERAPIST] (RT) CLOSED THE SUCTION CATHETER AND A NEW INLINE SUCTION CATHETER WAS PLACED AND THE LEAK DISAPPEARED COMPLETELY. IT WAS ADDITIONALLY REPORTED, DUE TO THE LEAK THE TEAM HAD TO: INCREASE THE VENTILATOR SETTINGS TO COMPENSATE FOR POOR GAS EXCHANGE; EXTRA MANIPULATION OF THE PATIENT¿S AIRWAYS WAS REQUIRED DUE TO THE EXCHANGE OF THE ENDOTRACHEAL TUBE (ETT); AND EXTRA PARALYTIC/SEDATION WAS GIVEN FOR THE PROCEDURE. IT WAS ALSO NOTED THAT ON-GOING BLOOD WAS BEING SUCTIONED FROM THE PATIENT¿S LUNGS. THERE WAS NO REPORTED INJURY TO THE PATIENT.

  Patient problems: Low Oxygen Saturation

  MAUDE report 17765920 ↗
• DeathSep 12, 2023Gas/Air Leak; Adverse Event Without Identified Device or Use Problem; Gas/Air Leak; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED ON 23OCT2023 REPORTED, ¿THE PATIENT WAS BROUGHT TO HOSPITAL [AFTER] HAVING BEEN FOUND IN A PARKING GARAGE. [THEY] RECEIVED BYSTANDER CARDIOPULMONARY RESUSCITATION (CPR). EVENTUALLY WHEN EHS ARRIVED THEY FOUND HIM TO BE IN A PULSELESS ELECTRICAL ACTIVITY (PEA) ARREST. HE REGAINED RETURN OF SPONTANEOUS CIRCULATION (ROSC) AND WAS BROUGHT IN TO THE EMERGENCY DEPARTMENT. HE WAS EVENTUALLY ADMITTED TO THE INTENSIVE CARE UNIT BUT ALREADY HAD SOME EARLY INDICATION OF POSSIBLE ANOXIC INJURY. THE PATIENT WAS MAINTAINED IN THE USUAL POST ARREST STATE AND FURTHER IMAGING DID REVEAL PROGRESSION OF ANOXIC BRAIN INJURY WITH COMPLETE LOSS OF DIFFERENTIATION AND EVENTUAL HERNIATION. THE PATIENT HAD LOST ALL BRAINSTEM REFLEXES, ALTHOUGH STILL WAS TRIGGERING THE MECHANICAL VENTILATOR. NEUROLOGICAL DECLARATION OF DEATH COULD NOT BE ESTABLISHED GIVEN THESE FINDINGS. AFTER SEVERAL DISCUSSIONS WITH THE FAMILY, EVENTUALLY A PLAN WAS MADE TO WITHDRAW CARE." IT WAS ADDITIONALLY REPORTED, THE CLOSED SUCTION CATHETER (CSC) HAD BEEN IN PLACE FOR ¿ROUGHLY 10 HOURS¿ AND THE THUMB VALVE WAS NOT OBSERVED TO HAVE BEEN IN THE DEPRESSED POSITION WHEN NOT IN USE. MULTIPLE ATTEMPTS WERE

  Patient problems: Low Oxygen Saturation

  MAUDE report 17730889 ↗
• MalfunctionJan 17, 2023Disconnection; Disconnection

  IT WAS REPORTED, THE NEW INLINE SUCTION SYSTEM DEVICE FOR THE TRACH FELL APART EASILY (IN 3 DIFFERENT AREAS); RECONNECTION WAS REQUIRED TO RECONNECT THE SECTION(S) THAT FELL OFF. PER ADDITIONAL INFORMATION RECEIVED ON 06JAN2023, THE CLOSED SUCTION CATHETER WAS NOT ALTERED IN ANY WAY. THE PRODUCT WAS PLACED ON THE SAME DAY THE INCIDENT OCCURRED. NO INJURY OR MEDICAL INTERVENTIONS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 16183736 ↗
• MalfunctionSep 29, 2022Disconnection; Disconnection

  IT WAS REPORTED THE "PATIENT['S] VENTILATOR TUBING DISCONNECTED FROM THE T-PIECE DURING MOBILIZATION AND FELL ONTO THE FLOOR." THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 15508912 ↗
• MalfunctionSep 13, 2022Disconnection; Disconnection

  IT WAS REPORTED THE "PT [PATIENT] WAS SUCTIONED AND WHILE PULLING THE CATHETER BACK OUT OF THE ENDOTRACHEAL TUBE THE CATHETER HOUSING/SLEEVE AND CONNECTOR (GREEN PLASTIC PORTION) BECAME DISCONNECTED FROM THE ELBOW CONNECTED TO THE ETT [ENDOTRACHEAL TUBE]. IT ALLOWED FOR THE SUCTION CATHETER TO BE OPEN TO AIR AND WAS NO LONGER A CLOSED SYSTEM." THERE WAS NO REPORTED INJURY. NO ADVERSE PATIENT IMPACT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15415286 ↗
• MalfunctionJul 31, 2020Break; Break

  IT WAS REPORTED, "THE INNER SWIVEL OF THE CLOSED SUCTION BROKE OFF FROM THE AIRWAY CONNECTOR." THERE WAS NO REPORTED INJURY. ADDITIONALLY, THE USERS NOTED THE INLINE SUCTION CATHETER BROKE IN MULTIPLE PLACES WHEN TRYING TO DISCONNECT THE SUCTION TUBING. THE TAPERED PLASTIC ADAPTER COMPLETELY DISCONNECTED FROM THE END OF THE DEVICE. FURTHERMORE, WHEN REMOVING A PINK SALINE AMPULE FROM THE SIDE PORT THE ENTIRE INTERIOR PORTION PULLED OUT AND THE TUBING HAD TO BE CLAMPED TO STOP THE CONTINUOUS LEAK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10349820 ↗