AVANOS 30788Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00193494307882), received between Aug 4, 2022 and Aug 4, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2022Material Integrity Problem; Material Integrity Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 2026095-2022-00084 FOR THE FIRST REPORT. IT WAS REPORTED, DURING REMOVAL OF THE ON-Q SOAKER CATHETER THE [CATHETER] SNAPPED AND REMAINED INSIDE THE PATIENT; A SIZABLE CHUNK OF THE CATHETER (APPROXIMATELY 10 CM) REMAINED INSIDE THE PATIENT. THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 14-JUL-2022 REPORTED, THE PRODUCT HAD BEEN IN PLACE FOR FOUR (4) DAYS, NO INJURY WAS REPORTED. THE REPORTER NOTED THAT IT WAS UNCLEAR IF THE PATIENT WOULD REQUIRE SURGERY TO REMOVE THE CATHETER. ADDITIONAL INFORMATION RECEIVED 18-JUL-2022 REPORTED, THE PATIENT WAS OFFERED TO GO BACK TO THE THEATRE, FOLLOWING THE CT SCAN BUT THERE WERE CONCERNS OF THE RISKS OF GOING BACK TO THE THEATRE SO SOON AFTER FIRST SURGERY, AND THE REPORTEDLY THE PATIENT DID NOT FEEL UP TO IT. THE PATIENT WAS STARTED ON IV ANTIBIOTICS TO COVER AS THE FOREIGN BODY REMAINS.

  Patient problems: Foreign Body In Patient

  MAUDE report 15167818 ↗
• MalfunctionAug 4, 2022Material Integrity Problem; Material Integrity Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 2026095-2022-00085 FOR THE SECOND REPORT. IT WAS REPORTED, DURING REMOVAL OF THE ON-Q SOAKER CATHETER THE [CATHETER] SNAPPED AND REMAINED INSIDE THE PATIENT; A SIZABLE CHUNK OF THE CATHETER (APPROXIMATELY 10 CM) REMAINED INSIDE THE PATIENT. THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 14-JUL-2022 REPORTED, THE PRODUCT WAS IN PLACE FOR FOUR (4) DAYS, NO INJURY WAS REPORTED. THE REPORTER NOTED THAT IT WAS UNCLEAR IF THE PATIENT WOULD REQUIRE SURGERY TO REMOVE THE CATHETER. ADDITIONAL INFORMATION RECEIVED 18-JUL-2022 REPORTED, THE PATIENT WAS DUE TO HAVE AN X-RAY ONCE STABLE, IN ORDER TO VISUALIZE THE MISSING CATHETER, WHICH WAS RADIO OPAQUE.

  Patient problems: Foreign Body In Patient

  MAUDE report 15167676 ↗