Ballard* Closed Suction System for Adults 98297Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00609038982977), received between Aug 22, 2022 and Apr 11, 2023 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Suction Problem” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 11, 2023Suction Problem; Suction Problem

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED SIX DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING SIX DIFFERENT EVENTS. THIS IS THE SECOND OF SIX REPORTS. REFER TO 8030647-2023-00067 FOR THE FIRST EVENT. REFER TO 8030647-2023-00069 FOR THE THIRD EVENT. REFER TO 8030647-2023-00070 FOR THE FOURTH EVENT. REFER TO 8030647-2023-00071 FOR THE FIFTH EVENT. REFER TO 8030647-2023-00072 FOR THE SIXTH EVENT. IT WAS REPORTED THE CLOSED SUCTION SYSTEM DID NOT SUCTION WHEN APPLIED, SUCTION CHECKED NOT THE CAUSE. DEVICE WAS REPLACED WITH A FURTHER CLOSED SUCTION SYSTEM SAME ISSUE, RESORTED TO OPEN SUCTION SYSTEMS AND NO ISSUES. BLOCKAGE NOTED IN CLOSED SYSTEM, "APPEARS TO LOOK FINE AND BUTTON PRESSING IS AS IF SUCTION SHOULD WORK BUT IT WAS NOT SUCKING WHEN APPLIED. NO VISIBLE SIGNS OF ANY BLOCKAGE." THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 16717780 ↗
• MalfunctionApr 11, 2023Suction Problem; Suction Problem

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED SIX DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING SIX DIFFERENT EVENTS. THIS IS THE SIXTH OF SIX REPORTS. REFER TO 8030647-2023-00067 FOR THE FIRST EVENT. REFER TO 8030647-2023-00068 FOR THE SECOND EVENT. REFER TO 8030647-2023-00069 FOR THE THIRD EVENT. REFER TO 8030647-2023-00070 FOR THE FOURTH EVENT. REFER TO 8030647-2023-00071 FOR THE FIFTH EVENT. IT WAS REPORTED THE CLOSED SUCTION SYSTEM DID NOT SUCTION WHEN APPLIED, SUCTION CHECKED NOT THE CAUSE. DEVICE WAS REPLACED WITH A FURTHER CLOSED SUCTION SYSTEM SAME ISSUE, RESORTED TO OPEN SUCTION SYSTEMS AND NO ISSUES. BLOCKAGE NOTED IN CLOSED SYSTEM, "APPEARS TO LOOK FINE AND BUTTON PRESSING IS AS IF SUCTION SHOULD WORK BUT IT WAS NOT SUCKING WHEN APPLIED. NO VISIBLE SIGNS OF ANY BLOCKAGE." THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 16717765 ↗
• MalfunctionApr 11, 2023Suction Problem; Suction Problem

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED SIX DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING SIX DIFFERENT EVENTS. THIS IS THE THIRD OF SIX REPORTS. REFER TO 8030647-2023-00067 FOR THE FIRST EVENT. REFER TO 8030647-2023-00068 FOR THE SECOND EVENT. REFER TO 8030647-2023-00070 FOR THE FOURTH EVENT. REFER TO 8030647-2023-00071 FOR THE FIFTH EVENT. REFER TO 8030647-2023-00072 FOR THE SIXTH EVENT. IT WAS REPORTED THE CLOSED SUCTION SYSTEM DID NOT SUCTION WHEN APPLIED, SUCTION CHECKED NOT THE CAUSE. DEVICE WAS REPLACED WITH A FURTHER CLOSED SUCTION SYSTEM SAME ISSUE, RESORTED TO OPEN SUCTION SYSTEMS AND NO ISSUES. BLOCKAGE NOTED IN CLOSED SYSTEM, "APPEARS TO LOOK FINE AND BUTTON PRESSING IS AS IF SUCTION SHOULD WORK BUT IT WAS NOT SUCKING WHEN APPLIED. NO VISIBLE SIGNS OF ANY BLOCKAGE." THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 16717653 ↗
• MalfunctionApr 11, 2023Suction Problem; Suction Problem

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED SIX DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING SIX DIFFERENT EVENTS. THIS IS THE FIFTH OF SIX REPORTS. REFER TO 8030647-2023-00067 FOR THE FIRST EVENT. REFER TO 8030647-2023-00068 FOR THE SECOND EVENT. REFER TO 8030647-2023-00069 FOR THE THIRD EVENT. REFER TO 8030647-2023-00070 FOR THE FOURTH EVENT. REFER TO 8030647-2023-00072 FOR THE SIXTH EVENT. IT WAS REPORTED THE CLOSED SUCTION SYSTEM DID NOT SUCTION WHEN APPLIED, SUCTION CHECKED NOT THE CAUSE. DEVICE WAS REPLACED WITH A FURTHER CLOSED SUCTION SYSTEM SAME ISSUE, RESORTED TO OPEN SUCTION SYSTEMS AND NO ISSUES. BLOCKAGE NOTED IN CLOSED SYSTEM, "APPEARS TO LOOK FINE AND BUTTON PRESSING IS AS IF SUCTION SHOULD WORK BUT IT WAS NOT SUCKING WHEN APPLIED. NO VISIBLE SIGNS OF ANY BLOCKAGE." THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 16717649 ↗
• MalfunctionApr 11, 2023Suction Problem; Suction Problem

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED SIX DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING SIX DIFFERENT EVENTS. THIS IS THE FOURTH OF SIX REPORTS. REFER TO 8030647-2023-00067 FOR THE FIRST EVENT. REFER TO 8030647-2023-00068 FOR THE SECOND EVENT. REFER TO 8030647-2023-00069 FOR THE THIRD EVENT. REFER TO 8030647-2023-00071 FOR THE FIFTH EVENT. REFER TO 8030647-2023-00072 FOR THE SIXTH EVENT. IT WAS REPORTED THE CLOSED SUCTION SYSTEM DID NOT SUCTION WHEN APPLIED, SUCTION CHECKED NOT THE CAUSE. DEVICE WAS REPLACED WITH A FURTHER CLOSED SUCTION SYSTEM SAME ISSUE, RESORTED TO OPEN SUCTION SYSTEMS AND NO ISSUES. BLOCKAGE NOTED IN CLOSED SYSTEM, "APPEARS TO LOOK FINE AND BUTTON PRESSING IS AS IF SUCTION SHOULD WORK BUT IT WAS NOT SUCKING WHEN APPLIED. NO VISIBLE SIGNS OF ANY BLOCKAGE." THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 16717642 ↗
• MalfunctionApr 11, 2023Suction Problem; Suction Problem

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED SIX DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING SIX DIFFERENT EVENTS. THIS IS THE FIRST OF SIX REPORTS. REFER TO 8030647-2023-00068 FOR THE SECOND EVENT. REFER TO 8030647-2023-00069 FOR THE THIRD EVENT. REFER TO 8030647-2023-00070 FOR THE FOURTH EVENT. REFER TO 8030647-2023-00071 FOR THE FIFTH EVENT. REFER TO 8030647-2023-00072 FOR THE SIXTH EVENT. IT WAS REPORTED THE CLOSED SUCTION SYSTEM DID NOT SUCTION WHEN APPLIED, SUCTION CHECKED NOT THE CAUSE. DEVICE WAS REPLACED WITH A FURTHER CLOSED SUCTION SYSTEM SAME ISSUE, RESORTED TO OPEN SUCTION SYSTEMS AND NO ISSUES. BLOCKAGE NOTED IN CLOSED SYSTEM, "APPEARS TO LOOK FINE AND BUTTON PRESSING IS AS IF SUCTION SHOULD WORK BUT IT WAS NOT SUCKING WHEN APPLIED. NO VISIBLE SIGNS OF ANY BLOCKAGE." THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 16717607 ↗
• MalfunctionAug 23, 2022Suction Failure; Suction Failure

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 8030647-2022-00187 FOR THE FIRST EVENT. IT WAS REPORTED THE SUCTIONING WAS WEAKER THAN USUAL. IT WAS FOUND DURING SUCTIONING. THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 15275428 ↗
• MalfunctionAug 22, 2022Suction Failure; Suction Failure

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 8030647-2022-00188 FOR THE SECOND EVENT. IT WAS REPORTED THE SUCTIONING WAS WEAKER THAN USUAL. IT WAS FOUND DURING SUCTIONING. THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 15272396 ↗