AVANOS 13535Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00193494135355), received between Jan 9, 2021 and Sep 17, 2026 — classified as 8 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Break

  It was reported that an ON-Q Antimicrobial Expansion Kit with SILVERSOAKER Catheter was placed in the epidural space immediately before an emergent cesarean section. Upon removal, staff observed that the catheter tip was not intact and appeared to be missing. Additional X-ray imaging was performed to assess for a retained foreign object; however, no retained foreign object was identified. The catheter tip was not located. No patient injury was identified.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50806194 ↗
• MalfunctionJul 17, 2024Break; Break

  IT WAS REPORTED, PAIN PUMP CATHETER BROKE WHEN PATIENT ATTEMPTED THE REMOVAL. THE CATHETER WAS NOT RADIOPAQUE ON IMAGING WHICH REQUIRED THE PATIENT TO RETURN TO THE OPERATING ROOM TO ATTEMPT REMOVAL VIA AN EXPLORATORY LAPAROTOMY. PATIENT EXPERIENCED A WOUND DUE TO THE ADDITIONAL SURGERY. PER ADDITIONAL INFORMATION RECEIVED ON 24JUN2024, THERE WAS NO ISSUE WITH THE PUMP. STAFF REPORTED THAT THE PATIENT PULLED THE CATHETER BUT WAS UNABLE TO SEE THE BLACK TIP; CATHETER NOT VISUALIZED VIA FLUOROSCOPIC IMAGING. EXPLORATORY LAP WAS PERFORMED, NO RETAINED PIECES OF CATHETER WERE FOUND.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body In Patient

  MAUDE report 19765103 ↗
• MalfunctionOct 30, 2023Break; Break

  IT WAS REPORTED THE "CATHETER [WAS] RETAINED IN [THE] PATIENT DURING [THE] REMOVAL PROCESS. BELIEVES IT MAY HAVE BEEN SUTURED IN, BUT UNSURE." THE PATIENT WAS RELEASED AFTER SPEAKING WITH THE PHYSICIAN, THERE WERE NO REPORTED INJURIES.

  Patient problems: Foreign Body In Patient

  MAUDE report 18029975 ↗
• MalfunctionDec 7, 2022Break; Break

  FILL VOLUME: UNKNOWN ML. FLOW RATE: UNKNOWN . PROCEDURE: L5/S1 TLIF, LEFT L5/S1 FACETECTOMY AND DISCECTOMY, L5 LAMINECTOMY. CATHPLACE: UNKNOWN . INFUSION START TIME: (B)(6)2022. INFUSION STOP TIME: (B)(6)2022. IT WAS REPORTED, DURING REMOVAL OF THE CATHETER FROM THE PATIENT THE ONQ CATHETER ¿BROKE OFF¿ AND THE PATIENT HAD TO RETURN TO THE OPERATING ROOM IN ORDER TO HAVE IT REMOVED. THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED (B)(6) 2022 REPORTED, THE CATHETER, WHICH WAS INSERTED ON (B)(6) 2022, WAS CAUGHT BY A SUTURE WHEN SEWING THE FASCIA CLOSED AND WAS NOTED AS A ¿TECHNICAL PROBLEM DURING SURGERY¿. THERE WAS NO REPORTED INJURY TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 15932674 ↗
• InjuryNov 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE FIRST OF TWO REPORTS. REFER TO 2026095-2022-00118 FOR THE SECOND REPORT. FILL VOLUME: UNKNOWN ML. FLOW RATE: UNKNOWN. PROCEDURE: REMOVAL OF LEFT OVARY. CATHPLACE: LAPAROTOMY PFANNENSTIEL INCISION. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED, THE PATIENT HAD A 10CM TERATOMA REMOVED ON (B)(6) 2022; THE SURGEON REMOVED THE LEFT OVARY WITH LAPAROTOMY P-FANNENSTIEL INCISION, THE SURGEON USED PM020-A (5" SILVER SOAKER CATHETER). ON (B)(6) 2022, THE ON-Q CATHETER WAS EMPTY, IT WAS REMOVED AT HOME. THE PATIENT REPORTED THE CATHETER CAME OUT EASILY; HOWEVER, 6 HOURS LATER THE PATIENT COMPLAINED OF PAIN AND SLIGHT SWELLING, THERE WAS NO BLEEDING OR OOZING FROM CATHETER SITES. ON (B)(6) 2022, THE PATIENT WAS ADMITTED BACK INTO THE HOSPITAL, WITH A HEMATOMA, WHERE THEY WERE TO UNDERGO AN ULTRASOUND AND POSSIBLE DRAINAGE OF THE SITE. ADDITIONAL INFORMATION RECEIVED ON 17 OCT 2022 THE PATIENT CONFIRMED THEY DID NOT EXPERIENCE ANY ISSUES AT THE TIME OF THE CATHETER REMOVAL. THEY ADDITIONALLY REPORTE

  Patient problems: Discomfort; Hematoma; Pain; Swelling/ Edema

  MAUDE report 15731165 ↗
• InjuryNov 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF TWO REPORTS. REFER TO 2026095-2022-00117 FOR THE FIRST REPORT. FILL VOLUME: UNKNOWN ML. FLOW RATE: UNKNOWN. PROCEDURE: REMOVAL OF LEFT OVARY. CATHPLACE: LAPAROTOMY PFANNENSTIEL INCISION. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED, THE PATIENT HAD A 10 CM TERATOMA REMOVED ON (B)(6) 2022; THE SURGEON REMOVED THE LEFT OVARY WITH LAPAROTOMY P-FANNENSTIEL INCISION, THE SURGEON USED PM020-A (5" SILVER SOAKER CATHETER). ON (B)(6) 2022, THE ON-Q CATHETER WAS EMPTY, IT WAS REMOVED AT HOME. THE PATIENT REPORTED THE CATHETER CAME OUT EASILY; HOWEVER, 6 HOURS LATER THE PATIENT COMPLAINED OF PAIN AND SLIGHT SWELLING, THERE WAS NO BLEEDING OR OOZING FROM CATHETER SITES. ON (B)(6) 2022, THE PATIENT WAS ADMITTED BACK INTO THE HOSPITAL, WITH A HEMATOMA, WHERE THEY WERE TO UNDERGO AN ULTRASOUND AND POSSIBLE DRAINAGE OF THE SITE. ADDITIONAL INFORMATION RECEIVED ON 17OCT2022 THE PATIENT CONFIRMED THEY DID NOT EXPERIENCE ANY ISSUES AT THE TIME OF THE CATHETER REMOVAL. THEY ADDITIONALLY REPORTED

  Patient problems: Discomfort; Hematoma; Pain; Swelling/ Edema

  MAUDE report 15729863 ↗
• MalfunctionAug 17, 2022Off-Label Use; Off-Label Use

  IT WAS REPORTED, THE MEDICAL PROFESSIONAL, CUT THE CATHETER DURING REMOVAL AND [THE CATHETER] WAS POSSIBLY BEING HELD IN PLACE BY A SUTURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 15239904 ↗
• MalfunctionJun 30, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT WHEN THE PATIENT ATTEMPTED TO REMOVE THE CATHETER, THEY MET RESISTANCE AND INSTEAD CUT THE CATHETER WHERE IT RETRACTED UNDER THE SKIN LEAVING IT UNABLE TO BE REMOVED. THERE WAS NO REPORT OF INJURY. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022, REPORTED THEY WILL NOT MAKE ANY DECISIONS ON REMOVAL UNTIL THE PATIENT HAS THEIR POST OPERATIVE APPOINTMENT IN A COUPLE OF WEEKS. THERE WAS NO REPORTED INJURY

  Patient problems: Foreign Body In Patient

  MAUDE report 14881224 ↗
• MalfunctionApr 19, 2022Break; Break

  IT WAS REPORTED THE CATHETER BROKE DURING USE. THE "PATIENT IS NOT SURE IF THE CATHETER WAS COMPLETELY REMOVED. SHE WASN¿T SURE IF SHE SAW THE BLACK TIP OF THE SILVER SOAKER CATHETER WHEN SHE REMOVED THE CATHETER." PER ADDITIONAL INFORMATION RECEIVED 22-APR-2022 THE PATIENT HAD UNDERWENT A TOTAL KNEE AMPUTATION (TKA).

  Patient problems: Foreign Body In Patient

  MAUDE report 14146339 ↗
• MalfunctionMay 14, 2021Break; Break

  FILL VOLUME: UNKNOWN, FLOW RATE: UNKNOWN, PROCEDURE: TOTAL KNEE AMPUTATION, (TKA) WITH AN ADDUCTOR, CATHPLACE: CANAL PLACEMENT. IT WAS REPORTED A BROKEN CATHETER, SILVERSOAKER, EVENT OCCURRED AS THE PATIENT WAS REMOVING THE CATHETER. THE BLACK TIP WAS NOT PRESENT. ADDITIONAL INFORMATION RECEIVED 23-APR-2021 STATED THE CATHETER APPEARED TO BE REALLY STRETCHED OUT. ADDITIONAL INFORMATION RECEIVED 27-APR-2021 STATED THE SURGEON WAS GOING TO LEAVE THE BROKEN CATHETER PIECE INSIDE THE PATIENT. THE PATIENT DID NOT HAVE ANY PAIN OR ISSUES. THE SURGEON MAY DECIDE TO TAKE X-RAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 11828861 ↗
• MalfunctionMay 13, 2021Break; Break

  IT WAS REPORTED THAT ONE OF THE CATHETERS PLACED IN THE PATIENT AFTER A TOTAL KNEE REPLACEMENT SURGERY BROKE. "THE PATIENT WAS STAYING OVERNIGHT AFTER THE PROCEDURE AND THIS INCIDENT HAPPENED SOMETIME DURING THE NIGHT. THE CATHETER WAS SECURED WITH SKIN GLUE, STERI STRIPS AND TEGADERM AFTER BEING PLACED. EVEN IF THE PATIENT ROLLED OVER WHILE SLEEPING, THIS WOULD HAVE TAKEN SOME AMOUNT OF FORCE TO BREAK WHERE IT DID. THE PAIN BALL WAS OUT OF THE WAY OF THE PATIENTS LEG AND ON THE BED NEXT TO THEM." PER ADDITIONAL INFORMATION RECEIVED VIA THE SALES REPRESENTATIVE, THE CATHETER PIECE WAS REMOVED FROM THE PATIENT. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 11821902 ↗
• InjuryJan 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AVANOS MEDICAL, INC. 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 2026095-2021-00008 FOR THE SECOND EVENT. REFER TO 2026095-2021-00009 FOR THE THIRD EVENT. REFER TO 2026095-2021-00010 FOR THE FOURTH EVENT. REFER TO 2026095-2021-00011 FOR THE FIFTH EVENT. REFER TO 2026095-2021-00012 FOR THE SIXTH EVENT. IT WAS REPORTED THAT PATIENT DEVELOPED A PELVIC INFECTION RIGHT AROUND WHERE THE CATHETER WAS INSERTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 11143866 ↗
• InjuryJan 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AVANOS MEDICAL, INC. 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 2026095-2021-00007 FOR THE FIRST EVENT. REFER TO 2026095-2021-00008 FOR THE SECOND EVENT. REFER TO 2026095-2021-00009 FOR THE THIRD EVENT. REFER TO 2026095-2021-00010 FOR THE FOURTH EVENT. REFER TO 2026095-2021-00011 FOR THE FIFTH EVENT. IT WAS REPORTED THAT PATIENT DEVELOPED A PELVIC INFECTION RIGHT AROUND WHERE THE CATHETER WAS INSERTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 11143855 ↗
• InjuryJan 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AVANOS MEDICAL, INC. 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 2026095-2021-00007 FOR THE FIRST EVENT. REFER TO 2026095-2021-00008 FOR THE SECOND EVENT. REFER TO 2026095-2021-00009 FOR THE THIRD EVENT. REFER TO 2026095-2021-00011 FOR THE FIFTH EVENT. REFER TO 2026095-2021-00012 FOR THE SIXTH EVENT. IT WAS REPORTED THAT PATIENT DEVELOPED A PELVIC INFECTION RIGHT AROUND WHERE THE CATHETER WAS INSERTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 11143817 ↗
• InjuryJan 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AVANOS MEDICAL, INC. 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 2026095-2021-00007 FOR THE FIRST EVENT. REFER TO 2026095-2021-00008 FOR THE SECOND EVENT. REFER TO 2026095-2021-00010 FOR THE FOURTH EVENT. REFER TO 2026095-2021-00011 FOR THE FIFTH EVENT. REFER TO 2026095-2021-00012 FOR THE SIXTH EVENT. IT WAS REPORTED THAT PATIENT DEVELOPED A PELVIC INFECTION RIGHT AROUND WHERE THE CATHETER WAS INSERTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 11143750 ↗
• InjuryJan 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AVANOS MEDICAL, INC. 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 2026095-2021-00007 FOR THE FIRST EVENT. REFER TO 2026095-2021-00009 FOR THE THIRD EVENT. REFER TO 2026095-2021-00010 FOR THE FOURTH EVENT. REFER TO 2026095-2021-00011 FOR THE FIFTH EVENT. REFER TO 2026095-2021-00012 FOR THE SIXTH EVENT. IT WAS REPORTED THAT PATIENT DEVELOPED A PELVIC INFECTION RIGHT AROUND WHERE THE CATHETER WAS INSERTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 11143748 ↗
• InjuryJan 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AVANOS MEDICAL, INC. 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 2026095-2021-00007 FOR THE FIRST EVENT. REFER TO 2026095-2021-00008 FOR THE SECOND EVENT. REFER TO 2026095-2021-00009 FOR THE THIRD EVENT. REFER TO 2026095-2021-00010 FOR THE FOURTH EVENT. REFER TO 2026095-2021-00012 FOR THE SIXTH EVENT. IT WAS REPORTED THAT PATIENT DEVELOPED A PELVIC INFECTION RIGHT AROUND WHERE THE CATHETER WAS INSERTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 11143613 ↗