Ballard* Turbo-Cleaning Closed Suction System 98255Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00609038982557), received between Jul 28, 2020 and Apr 22, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 22, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED, THE CLOSED SUCTION SYSTEM BROKE WHILE IT WAS CONNECTED TO A PATIENT WHO WAS BEING MOBILIZED TO THE PRONE POSITION. THERE WAS NO REPORTED INJURY TO THE PATIENT. NO MEDICAL INTERVENTION WAS REQUIRED. ADDITIONAL INFORMATION RECEIVED 02APR2024, PER GOOGLE TRANSLATE REPORTED, "THE GUIDE BECAME FRAYED DURING INSTALLATION OF THE KTA WHEN REMOVING THE GUIDE. THE GUIDE DID NOT BREAK SHARPLY. THE WIRES THAT HAVE BROKEN ARE MORE LOCATED ON THE MIDDLE PART OF THE GUIDE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19152291 ↗
• MalfunctionJan 18, 2024Break; Break

  IT WAS REPORTED, "ON WARNING SIGN: SPASTIC INTUBATED PATIENT, CALL TO THE DOCTOR BY THE NURSE." A PIECE OF PLASTIC WAS VISUALIZED IN THE INTUBATION TUBE. "MATERIAL INSPIRED BY PATIENT." FIBROSCOPY PERFORMED ON (B)(6) 2023 TO RETRIEVE RETAINED PIECE OF PLASTIC WHICH APPEARED TO CORRESPOND WITH THE VALVE ON THE CLOSED SUCTION CATHETER. "THE SYSTEM HAD BEEN IN PLACE FOR LESS THAN 72 HOURS AND RINSED WITH SALINE AS RECOMMENDED." THE CLOSED SUCTION SYSTEM WAS REMOVED; THERE WAS NO REPORTED INJURY TO THE PATIENT.

  Patient problems: Aspiration/Inhalation

  MAUDE report 18535609 ↗
• MalfunctionJul 28, 2020Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE USER WAS UNABLE TO "REASSEMBLE" THE SUCTION CATHETER. THE SUCTION TUBE WAS "HALF BLOCKED" IN THE PATIENT'S TRACHEA AND BRONCHUS. THE PATIENT WAS THEN DISCONNECTED FROM THE VENT CIRCUIT TO REMOVE THE SYSTEM. THERE WERE NO OTHER CONSEQUENCES TO THE PATIENT. PER ADDITIONAL INFORMATION RECEIVED ON 15 JUL 2020, THE ISSUE WAS THAT THE CATHETER COULD NOT BE RETURNED TO THE ORIGINAL POSITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10332368 ↗