Ballard* Closed Suction System for Adults 98316Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00609038983165), received between May 25, 2023 and Nov 19, 2024 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Suction Failure” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 19, 2024Crack; Material Integrity Problem; Crack; Material Integrity Problem

  IT WAS REPORTED, THE DEVICE FRACTURED AT THE ELBOW WHILE THE PATIENT WAS BEING SUCTIONED; THE DEVICE WHICH HAD BEEN IN PLACE FOR LESS THAN 20 HOURS, WAS CHANGED; THERE WAS NO REPORTED INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20723584 ↗
• MalfunctionJun 4, 2024Suction Failure; Suction Failure

  IT WAS REPORTED, THE TRACH CARE PROBE DID NOT ASPIRATE THE PATIENT'S SECRETIONS, IT WAS REPLACED, AND THE PATIENT WAS ABLE TO BE ASPIRATED. IT WAS ADDITIONALLY REPORTED, NO VISIBLE DAMAGE TO THE PATIENT, WAS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19459890 ↗
• MalfunctionSep 13, 2023Blocked Connection; Suction Failure; Blocked Connection; Suction Failure

  IT WAS REPORTED, THE PATIENT IN THE INTENSIVE CARE UNIT REQUIRED ENDOTRACHEAL SUCTIONING; HOWEVER, THE PROCEDURE COULD NOT BE PERFORMED AS THE SUCTION VALVE DID NOT WORK NOR DID IT ALLOW WASHING OF THE PROBE. WHEN THE VALVE WAS PRESSED, THE DEVICE WAS BLOCKED AND DID NOT ASPIRATE SECRETIONS. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS PERFORMED WITHOUT "AFFECTING" THE PATIENT. NO INJURY REPORTED. THE PATIENT WAS REPORTED TO BE DOING WELL AND WAS BEING MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17735970 ↗
• InjuryAug 17, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE CLOSED SUCTION CATHETER HAD AN EXTRA PIECE OF PLASTIC OCCLUDING THE TRACH CARE, WHICH PREVENTED THE CLOSED SUCTION CATHETER FROM MOVING FREELY THROUGH AND POTENTIALLY OCCLUDING THE AIRWAY. THE PRODUCT WAS IN USE FOR FIVE MINUTES. THE PATIENT DESATURATED AND DETERIORATED. THE PATIENT WAS MANUALLY BAGGED AND SATURATIONS STABILIZED. A NEW DEVICE WAS USED WITHOUT ANY FURTHER INCIDENT. THE PATIENT WAS REPORTED TO BE OK. PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2023, ¿STAFF DESCRIBED IT [LOCATION OF BLOCKAGE] AS THE TRACH CARE BARREL - THERE WAS A THIN FILM OF PLASTIC OCCLUDING THE TRACH CARE BARREL, WHICH ALSO PREVENTED THE SUCTION CATHETER FROM MOVING FREELY THROUGH, AND POTENTIALLY OCCLUDING THE AIRWAY.¿ A NEW TRACH CARE WAS PLACED WITH THE SAME LOT NUMBER, AND NO ISSUES OCCURRED WITH THE NEW DEVICE. THE DETERIORATION WAS WITNESSED BY STAFF AND THE PATIENT RECOVERED AFTER IMMEDIATE MEDICAL ATTENTION. THE PATIENT REMAINS IN INTENSIVE THERAPY UNIT (ITU) ¿ STABLE.

  Patient problems: Airway Obstruction; Low Oxygen Saturation

  MAUDE report 17564665 ↗
• MalfunctionJul 27, 2023Blocked Connection; Suction Failure; Blocked Connection; Suction Failure

  IT WAS REPORTED, THE PATIENT IN THE INTENSIVE CARE UNIT REQUIRED ENDOTRACHEAL SUCTIONING; HOWEVER, THE PROCEDURE COULD NOT BE PERFORMED AS THE SUCTION VALVE DID NOT WORK NOR DID IT ALLOW WASHING OF THE PROBE. WHEN THE VALVE WAS PRESSED, THE DEVICE WAS BLOCKED AND DID NOT ASPIRATE SECRETIONS. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS PERFORMED WITHOUT ¿AFFECTING¿ THE PATIENT. NO INJURY REPORTED. THE PATIENT WAS REPORTED TO BE DOING WELL AND WAS BEING MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17410265 ↗
• InjuryMay 25, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE CLOSED SUCTION CATHETER HAD AN EXTRA PIECE OF PLASTIC OCCLUDING THE TRACH CARE, WHICH PREVENTED THE CLOSED SUCTION CATHETER FROM MOVING FREELY THROUGH AND POTENTIALLY OCCLUDING THE AIRWAY. THE PRODUCT WAS IN USE FOR FIVE MINUTES. THE PATIENT DESATURATED AND DETERIORATED. THE PATIENT WAS MANUALLY BAGGED AND SATURATIONS STABILIZED. A NEW DEVICE WAS USED WITHOUT ANY FURTHER INCIDENT. THE PATIENT WAS REPORTED TO BE OK. PER ADDITIONAL INFORMATION RECEIVED ON 16MAY2023, ¿STAFF DESCRIBED IT [LOCATION OF BLOCKAGE] AS THE TRACH CARE BARREL - THERE WAS A THIN FILM OF PLASTIC OCCLUDING THE TRACH CARE BARREL, WHICH ALSO PREVENTED THE SUCTION CATHETER FROM MOVING FREELY THROUGH, AND POTENTIALLY OCCLUDING THE AIRWAY.¿ A NEW TRACH CARE WAS PLACED WITH THE SAME LOT NUMBER, AND NO ISSUES OCCURRED WITH THE NEW DEVICE. THE DETERIORATION WAS WITNESSED BY STAFF AND THE PATIENT RECOVERED AFTER IMMEDIATE MEDICAL ATTENTION. THE PATIENT REMAINS IN INTENSIVE THERAPY UNIT (ITU) ¿ STABLE.

  Patient problems: Airway Obstruction; Low Oxygen Saturation

  MAUDE report 17003102 ↗