Ballard* Turbo-Cleaning Closed Suction System 98263Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00609038982632), received between Jul 14, 2020 and Dec 8, 2020 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Disconnection” (11 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-1526-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 8, 2020Disconnection; Disconnection

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING DIFFERENT PATIENTS. THIS IS THE SEVENTH OF TEN REPORTS. REFER TO 8030647-2020-00104 FOR THE FIRST REPORT. REFER TO 8030647-2020-00105 FOR THE SECOND REPORT . REFER TO 8030647-2020-00106 FOR THE THIRD REPORT . REFER TO 8030647-2020-00107 FOR THE FOURTH REPORT. REFER TO 8030647-2020-00108 FOR THE FIFTH REPORT. REFER TO 8030647-2020-00109 FOR THE SIXTH REPORT. REFER TO 8030647-2020-00111 FOR THE EIGHTH REPORT. REFER TO 8030647-2020-00112 FOR THE NINTH REPORT. REFER TO 8030647-2020-00113 FOR THE TENTH REPORT. IT WAS REPORTED THAT THE FLEX TUBE [FLEX CONNECTOR] DISCONNECTED FROM THE CLOSED SUCTION SYSTEM. PRODUCT WAS IN USE FOR ONE TO THREE DAYS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10971092 ↗
• MalfunctionDec 8, 2020Disconnection; Disconnection

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING DIFFERENT PATIENTS. THIS IS THE FOURTH OF TEN REPORTS. REFER TO 8030647-2020-00104 FOR THE FIRST REPORT. REFER TO 8030647-2020-00105 FOR THE SECOND REPORT. REFER TO 8030647-2020-00106 FOR THE THIRD REPORT. REFER TO 8030647-2020-00108 FOR THE FIFTH REPORT. REFER TO 8030647-2020-00109 FOR THE SIXTH REPORT. REFER TO 8030647-2020-00110 FOR THE SEVENTH REPORT. REFER TO 8030647-2020-00111 FOR THE EIGHTH REPORT. REFER TO 8030647-2020-00112 FOR THE NINTH REPORT. REFER TO 8030647-2020-00113 FOR THE TENTH REPORT. IT WAS REPORTED THAT THE FLEX TUBE [FLEX CONNECTOR] DISCONNECTED FROM THE CLOSED SUCTION SYSTEM. PRODUCT WAS IN USE FOR ONE TO THREE DAYS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10971050 ↗
• MalfunctionDec 8, 2020Disconnection; Disconnection

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING DIFFERENT PATIENTS. THIS IS THE TENTH OF TEN REPORTS. REFER TO 8030647-2020-00104 FOR THE FIRST REPORT . REFER TO 8030647-2020-00105 FOR THE SECOND REPORT . REFER TO 8030647-2020-00106 FOR THE THIRD REPORT . REFER TO 8030647-2020-00107 FOR THE FOURTH REPORT. REFER TO 8030647-2020-00108 FOR THE FIFTH REPORT. REFER TO 8030647-2020-00109 FOR THE SIXTH REPORT. REFER TO 8030647-2020-00110 FOR THE SEVENTH REPORT. REFER TO 8030647-2020-00111 FOR THE EIGHTH REPORT. REFER TO 8030647-2020-00112 FOR THE NINTH REPORT. IT WAS REPORTED THAT THE FLEX TUBE [FLEX CONNECTOR] DISCONNECTED FROM THE CLOSED SUCTION SYSTEM. PRODUCT WAS IN USE FOR ONE TO THREE DAYS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10971013 ↗
• MalfunctionDec 8, 2020Disconnection; Disconnection

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING DIFFERENT PATIENTS. THIS IS THE SIXTH OF TEN REPORTS. REFER TO 8030647-2020-00104 FOR THE FIRST REPORT. REFER TO 8030647-2020-00105 FOR THE SECOND REPORT. REFER TO 8030647-2020-00106 FOR THE THIRD REPORT . REFER TO 8030647-2020-00107 FOR THE FOURTH REPORT. REFER TO 8030647-2020-00108 FOR THE FIFTH REPORT. REFER TO 8030647-2020-00110 FOR THE SEVENTH REPORT. REFER TO 8030647-2020-00111 FOR THE EIGHTH REPORT. REFER TO 8030647-2020-00112 FOR THE NINTH REPORT. REFER TO 8030647-2020-00113 FOR THE TENTH REPORT IT WAS REPORTED THAT THE FLEX TUBE [FLEX CONNECTOR] DISCONNECTED FROM THE CLOSED SUCTION SYSTEM. PRODUCT WAS IN USE FOR ONE TO THREE DAYS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10970996 ↗
• MalfunctionDec 8, 2020Disconnection; Disconnection

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING DIFFERENT PATIENTS. THIS IS THE NINTH OF TEN REPORTS. REFER TO 8030647-2020-00104 FOR THE FIRST REPORT . REFER TO 8030647-2020-00105 FOR THE SECOND REPORT . REFER TO 8030647-2020-00106 FOR THE THIRD REPORT . REFER TO 8030647-2020-00107 FOR THE FOURTH REPORT. REFER TO 8030647-2020-00108 FOR THE FIFTH REPORT. REFER TO 8030647-2020-00109 FOR THE SIXTH REPORT. REFER TO 8030647-2020-00110 FOR THE SEVENTH REPORT. REFER TO 8030647-2020-00111 FOR THE EIGHTH REPORT. REFER TO 8030647-2020-00113 FOR THE TENTH REPORT. IT WAS REPORTED THAT THE FLEX TUBE [FLEX CONNECTOR] DISCONNECTED FROM THE CLOSED SUCTION SYSTEM. PRODUCT WAS IN USE FOR ONE TO THREE DAYS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10970995 ↗
• MalfunctionDec 8, 2020Disconnection; Disconnection

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING DIFFERENT PATIENTS. THIS IS THE THIRD OF TEN REPORTS. REFER TO 8030647-2020-00104 FOR THE FIRST REPORT. REFER TO 8030647-2020-00105 FOR THE SECOND REPORT. REFER TO 8030647-2020-00107 FOR THE FOURTH REPORT. REFER TO 8030647-2020-00108 FOR THE FIFTH REPORT. REFER TO 8030647-2020-00109 FOR THE SIXTH REPORT. REFER TO 8030647-2020-00110 FOR THE SEVENTH REPORT. REFER TO 8030647-2020-00111 FOR THE EIGHTH REPORT. REFER TO 8030647-2020-00112 FOR THE NINTH REPORT. REFER TO 8030647-2020-00113 FOR THE TENTH REPORT. IT WAS REPORTED THAT THE FLEX TUBE [FLEX CONNECTOR] DISCONNECTED FROM THE CLOSED SUCTION SYSTEM. PRODUCT WAS IN USE FOR ONE TO THREE DAYS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10970991 ↗
• MalfunctionDec 8, 2020Disconnection; Disconnection

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING DIFFERENT PATIENTS. THIS IS THE EIGHTH OF TEN REPORTS. REFER TO 8030647-2020-00104 FOR THE FIRST REPORT. REFER TO 8030647-2020-00105 FOR THE SECOND REPORT. REFER TO 8030647-2020-00106 FOR THE THIRD REPORT. REFER TO 8030647-2020-00107 FOR THE FOURTH REPORT. REFER TO 8030647-2020-00108 FOR THE FIFTH REPORT. REFER TO 8030647-2020-00109 FOR THE SIXTH REPORT. REFER TO 8030647-2020-00110 FOR THE SEVENTH REPORT. REFER TO 8030647-2020-00112 FOR THE NINTH REPORT. REFER TO 8030647-2020-00113 FOR THE TENTH REPORT. IT WAS REPORTED THAT THE FLEX TUBE [FLEX CONNECTOR] DISCONNECTED FROM THE CLOSED SUCTION SYSTEM. PRODUCT WAS IN USE FOR ONE TO THREE DAYS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10970990 ↗
• MalfunctionDec 8, 2020Disconnection; Disconnection

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING DIFFERENT PATIENTS. THIS IS THE FIFTH OF TEN REPORTS. REFER TO 8030647-2020-00104 FOR THE FIRST REPORT. REFER TO 8030647-2020-00105 FOR THE SECOND REPORT. REFER TO 8030647-2020-00106 FOR THE THIRD REPORT. REFER TO 8030647-2020-00107 FOR THE FOURTH REPORT. REFER TO 8030647-2020-00109 FOR THE SIXTH REPORT. REFER TO 8030647-2020-00110 FOR THE SEVENTH REPORT. REFER TO 8030647-2020-00111 FOR THE EIGHTH REPORT. REFER TO 8030647-2020-00112 FOR THE NINTH REPORT. REFER TO 8030647-2020-00113 FOR THE TENTH REPORT. IT WAS REPORTED THAT THE FLEX TUBE (FLEX CONNECTOR) DISCONNECTED FROM THE CLOSED SUCTION SYSTEM. PRODUCT WAS IN USE FOR ONE TO THREE DAYS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10970980 ↗
• MalfunctionDec 8, 2020Disconnection; Disconnection

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING DIFFERENT PATIENTS. THIS IS THE SECOND OF TEN REPORTS. REFER TO 8030647-2020-00104 FOR THE FIRST REPORT. REFER TO 8030647-2020-00106 FOR THE THIRD REPORT. REFER TO 8030647-2020-00107 FOR THE FOURTH REPORT. REFER TO 8030647-2020-00108 FOR THE FIFTH REPORT. REFER TO 8030647-2020-00109 FOR THE SIXTH REPORT. REFER TO 8030647-2020-00110 FOR THE SEVENTH REPORT. REFER TO 8030647-2020-00111 FOR THE EIGHTH REPORT. REFER TO 8030647-2020-00112 FOR THE NINTH REPORT. REFER TO 8030647-2020-00113 FOR THE TENTH REPORT. IT WAS REPORTED THAT THE FLEX TUBE [FLEX CONNECTOR] DISCONNECTED FROM THE CLOSED SUCTION SYSTEM. PRODUCT WAS IN USE FOR ONE TO THREE DAYS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10970957 ↗
• MalfunctionDec 8, 2020Disconnection; Disconnection

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING DIFFERENT PATIENTS. THIS IS THE FIRST OF TEN REPORTS. REFER TO 8030647-2020-00105 FOR THE SECOND REPORT. REFER TO 8030647-2020-00106 FOR THE THIRD REPORT. REFER TO 8030647-2020-00107 FOR THE FOURTH REPORT. REFER TO 8030647-2020-00108 FOR THE FIFTH REPORT. REFER TO 8030647-2020-00109 FOR THE SIXTH REPORT. REFER TO 8030647-2020-00110 FOR THE SEVENTH REPORT. REFER TO 8030647-2020-00111 FOR THE EIGHTH REPORT. REFER TO 8030647-2020-00112 FOR THE NINTH REPORT. REFER TO 8030647-2020-00113 FOR THE TENTH REPORT. IT WAS REPORTED THAT THE FLEX TUBE [FLEX CONNECTOR] DISCONNECTED FROM THE CLOSED SUCTION SYSTEM. PRODUCT WAS IN USE FOR ONE TO THREE DAYS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10970953 ↗
• MalfunctionJul 14, 2020Disconnection; Disconnection

  IT WAS REPORTED THAT DURING THE TIME PERIOD WHERE THE HOSPITAL WAS TREATING COVID PATIENTS, THERE WAS AN ISSUE WITH DISCONNECTION BETWEEN THE CLOSED SUCTION SYSTEM AND THE TWINSTAR 90 DRAËGER PATIENT FILTER (REFERENCE (B)(4)). THE ALLEGED RESULT OF THIS DISCONNECTION WAS HYPOXIC BRADYCARDIA. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: Bradycardia; Hypoxia

  MAUDE report 10273012 ↗