AVANOS 13533Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00193494135331), received between May 7, 2022 and Sep 9, 2026 — classified as 9 malfunctions.

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

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Break

  Patient problems: Foreign Body In Patient

  MAUDE report 50699960 ↗
• MalfunctionSep 16, 2025Break; Break

  PROCEDURE: UNKNOWN CATH PLACE: INTRA-ARTICULAR IT WAS REPORTED THERE WAS A SILVER SOAKER CATHETER "BREAK OFF INTO A PATIENT UPON REMOVAL." THE DOCTOR DID REMOVE THE REMAINING CATHETER SURGICALLY..." ADDITIONAL INFORMATION RECEIVED 27-AUG-2025 NOTED THE "PATIENT WAS TAKEN BACK TO THE OR (OPERATING ROOM) TO REMOVE THE CATHETER (B)(6) 2025." A SMALL INCISION WAS MADE AT THE SKIN AND THE ENTIRE CATHETER WAS REMOVED WITH NO ISSUE. THE "PATIENT WAS REMOVING THE CATHETER AND IT SNAPPED OFF. A PORTION OF THE DISTAL END OF THE CATHETER REMAINED INSIDE THE PATIENT¿S KNEE." THE CATHETER WAS SECURED ON THE PATIENT VIA DERMABOND/ 2X2 AND TEGADERM. THE PATIENT EXPERIENCED DISCOMFORT DURING THE CATHETER REMOVAL. THERE WAS TENSION REMOVING THE CATHETER AND IT SNAPPED." ABOUT SIX INCHES OF THE CATHETER WAS RETAINED INSIDE THE PATIENT. THE CATHETER WAS REMOVED ON (B)(6) 2025. THERE WAS NO REPORTED INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 23068942 ↗
• MalfunctionJul 30, 2025Break; Break

  IT WAS REPORTED A SILVER SOAKER CATHETER BROKE OFF. IT APPEARED THE CATHETER GOT SNAGGED AND PULLED OUT, BUT THE BLACK TIP WAS NOT VISIBLE. THE MEDICAL DOCTOR REQUESTED AN X-RAY TO VERIFY IF THE TIP WAS STILL IN THE PATIENT. ADDITIONAL INFORMATION RECEIVED 3-JUL-2025 NOTING THE MEDICAL TEAM HAD AN X-RAY PERFORMED BUT COULD NOT VALIDATE IF THE CATHETER TIP WAS VISIBLE, SO THE MEDICAL TEAM WAS GOING TO ORDER AN MAGNETIC RESONANCE IMAGING (MRI). ADDITIONAL INFORMATION RECEIVED 08-JUL-2025 NOTING AN MRI WAS NOT PERFORMED, NO FURTHER ACTION WAS TAKEN. THE PATIENT IS DOING WELL, AND NO FURTHER ACTION WILL BE TAKEN AT THIS TIME. THERE WAS NO REPORTED INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 22672401 ↗
• MalfunctionJul 30, 2025Break; Break

  IT WAS REPORTED THERE WAS BREAK IN THE CATHETER. "THE PHYSICIAN MAY HAVE DAMAGED IT ON THE PLACEMENT" BUT UNSURE. THERE WAS NO PATIENT INJURY. A NEW CATHETER WAS PLACED WITH NO ISSUE." ADDITIONAL INFORMATION RECEIVED 03-JUL-2025 NOTING THE CATHETER BROKE INSIDE THE PATIENT BUT "IT SEEMED MORE LIKE A HOLE VERSUS BREAKING OFF." THE PATIENT IS DOING "GOOD/NO ISSUES REPORTED." THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22667591 ↗
• MalfunctionJun 18, 2024Break; Break

  IT WAS REPORTED THE "DISTAL MARKINGS ON CATHETER NOT PRESENT UPON REMOVAL. CATHETER BELIEVED BY NURSING STAFF TO HAVE SNAPPED INTERNALLY." THE WAS NO REPORTED PATIENT INJURY NOR MEDICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19562785 ↗
• MalfunctionMay 10, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED, A PORTION OF A CATHETER USED FOR AN ADDUCTOR CANAL PLACEMENT (TKA) WAS RETAINED IN A PATIENT; THE REGISTERED NURSE (RN) ATTEMPTED TO REMOVE THE CATHETER BY PLACING A WARM COMPRESS OVER THE CATHETER INSERTION SITE BUT WAS MET WITH RESISTANCE. THE PATIENT HAD AN APPOINTMENT TO FOLLOW UP WITH THE DOCTOR ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED 12APR2023 REPORTED, THE CATHETER WAS PLACED ON (B)(6) 2023 AND HAD BEEN IN PLACE FOR 4 HOURS WHEN THE RN MET WITH EXTREME RESISTANCE DURING REMOVAL. THE PHYSICIAN WAS ABLE TO REMOVE IT IN THE OFFICE, THE PROCEDURE REQUIRED 4 STITCHES; THE PATIENT¿S CURRENT CONDITION WAS NOT REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16901951 ↗
• MalfunctionDec 22, 2022Material Integrity Problem; Material Integrity Problem

  FDA MEDWATCH / FDA USER FACILITY REPORT #: MW5113442 REPORTED ON 24OCT2022, ¿WHEN DISCONTINUING ONQ PUMP TODAY-MOST POSTERIOR CATHETER FRACTURED INSIDE PATIENT.¿

  Patient problems: Foreign Body In Patient

  MAUDE report 16039806 ↗
• MalfunctionJul 28, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A CATHETER MAY HAVE BROKEN OFF DURING THE REMOVAL PROCESS; THE DOCTOR COULD NOT LOCATE THE BLACK TIP AND THE PATIENT STATED THEY HEARD A SNAP. IT [THE BLACK TIP] DID NOT SHOW UP ON THE X-RAY; THE PATIENT WAS NOT HAVING ANY ISSUES. THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022 REPORTED, THE PATIENT WAS NOT EXPERIENCING ANY SYMPTOMS OR DISCOMFORT.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 15118923 ↗
• MalfunctionMay 7, 2022Break; Break

  IT WAS REPORTED THAT A PORTION OF A SILVER SOAKER CATHETER WAS RETAINED INSIDE OF THE PATIENT; A COMPUTED TOMOGRAPHY SCAN (CT) ABDOMEN/PELVIS WAS PERFORMED AND READ AS NO FINDINGS. THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 11APR2022 REPORTED THAT THE CATHETER WAS SECURED WITH TEGADERM ONLY AND THE PATIENT DID NOT EXPRESS THAT ANY RESISTANCE WAS MET DURING INSERTION OR REMOVAL OF THE CATHETER, AN XRAY OF THE ABDOMEN, PELVIS AND CHEST WERE PERFORMED. THE PATIENT WAS REPORTEDLY IN STABLE CONDITION; THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 02MAY2022 THE PATIENT REPORTED THAT THEY WERE ON SEVERAL ANTIBIOTICS DUE TO REDNESS AND DRAINAGE FROM THE INCISION SITE ON THE RIGHT SIDE OF THE ABDOMEN AND BELLY BUTTON. CULTURES PERFORMED ON THE DRAINAGE, DURING A ROUTINE POST-OP VISIT REVEALED THE GROWTH OF PSEUDOMONAS STUTZERI AND PREVOTELLA ORALIS, THE PATIENT WAS PRESCRIBED ANTIBIOTIC TREATMENT OVER THE PAST MONTH. THE PATIENT REPORTED THAT THE INCISION SITE DRAINAGE AND REDNESS HAD IMPROVED AND THERE WAS NO FEVER OR OTHER SERIOUS SIGNS OF INFECTIONS. THE PATIENT REPORTEDLY WAS VERY WORRIED THAT THE DISTAL PORTION OF THE CATHETER REMAINED INSIDE OF THE P

  Patient problems: Bacterial Infection; Foreign Body In Patient

  MAUDE report 14315959 ↗