AVANOS 13541Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00193494135416), received between May 14, 2021 and Feb 17, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 17, 2026Break

  MAUDE ADVERSE EVENT REPORT NUMBER: (B)(4): ¿THIS PATIENT HAD BILATERAL PARASTERNAL SILVER SOAKER NERVE BLOCK CATHETERS PLACED ON [REDACTED] THAT WERE REMOVED ON [REDACTED]. THE LEFT CATHETER CAME OUT EASILY WITH TIP INTACT. THE RIGHT CATHETER SHEARED, LEAVING REMNANT IN CHEST WALL, ~5CM. AN ULTRASOUND WAS OBTAINED TO IDENTIFY THE POSITION OF THE NERVE CATHETER IN THE SUBCUTANEOUS TISSUES OF THE RIGHT CHEST. IT WAS SUBSEQUENTLY REMOVED VIA A SMALL INCISION.¿

  Patient problems: Foreign Body In Patient

  MAUDE report 24367356 ↗
• MalfunctionJul 1, 2025Break; Break

  IT WAS REPORTED, DOCTOR REMOVED CATHETER FROM A RIB FRACTURE PATIENT BUT DID NOT SEE THE BLACK TIP. CT PERFORMED AND CONFIRMED THE CATHETER HAD BROKEN OFF IN THE PATIENT. THE RETAINED PORTION WAS REMOVED SUCCESSFULLY. PATIENT WAS REPORTED TO BE DOING WELL AND WAS PLANNING ON BEING DISCHARGED THE NEXT DAY. PER ADDITIONAL INFORMATION RECEIVED ON 9JUN2025, THE CATHETER BROKE INSIDE OF THE PATIENT. THE CATHETER WAS NOT SUTURED. THE CATHETER WAS SECURED TO THE PATIENT WITH DERMABOND, STERI-STRIPS AND TWO TEGADERMS. MODERATE RESISTANCE WAS MET WHEN ATTEMPTING TO REMOVE THE CATHETER. THE RETAINED PORTION OF THE CATHETER WAS REMOVED SURGICALLY ON (B)(6) 2025. REMOVAL WAS PERFORMED ABOVE THE SCAPULA, DIRECT CUT DOWN WITH ULTRASOUND PROVE GUIDANCE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22373775 ↗
• MalfunctionApr 1, 2022Break; Break

  IT WAS REPORTED "THE PHYSICIAN NOTED THE PATIENT DID NOT REMOVE THE CATHETER WHEN SHE WAS TOLD TO; IT WAS LEFT IN LONGER THAN EXPECTED. THE PHYSICIAN WILL BE SEEING THE PATIENT IN THE OFFICE AND WILL OBTAIN X-RAY TO SEE IF THERE IS A CATHETER INSIDE THE OP-SITE (TKR). THE PHYSICIAN DIDN'T KNOW WHETHER OR NOT THE CATHETER BROKE OFF FOR SURE BUT WILL OBTAIN AND X-RAY FOR CONFIRMATION." ADDITIONAL INFORMATION RECEIVED 15-MAR-2022 FROM THE PHYSICIAN STATED THE X-RAY DID NOT SHOW A CATHETER SEGMENT RETAINED INSIDE OF THE PATIENT. AN X-RAY OF A CATHETER ONLY WAS PERFORMED IN THE DOCTORS OFFICE. THE PHYSICIAN NOTED THE X-RAY WAS "VERY HARD TO SEE" AND THE PHYSICIAN WOULD NOT CALL THEM RADIOPAQUE.

  Patient problems: Insufficient Information

  MAUDE report 13981081 ↗
• InjuryMay 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH). CATHPLACE: UNKNOWN. IT WAS REPORTED "PATIENT USED ON-Q PUMP AND CATHETER AND DEVELOPED A PELVIC ABSCESS WHICH IS GROWING FUNGUS AND BACTEROIDS." THE CLINICAL RESEARCH COORDINATOR DETAILED THE FOLLOWING INCIDENT: PATIENT USED ON-Q PUMP FOR 72-HOURS AFTER UNDERGOING MINIMALLY INVASIVE HYSTERECTOMY PROCEDURE. POST-OPERATIVE COURSE COMPLICATED BY PROLONGED FEVERS AND ABDOMINAL PAIN. PATIENT EVENTUALLY UNDERWENT CT ABDOMEN/PELVIS EXAM, SHOWING AN 8 CM MASS. PATIENT ADMITTED TO HOSPITAL CENTER ON (B)(6) 2021. PATIENT UNDERWENT TOTAL LAPAROSCOPIC HYSTERECTOMY ON (B)(6) 2021 AT MEDICAL CENTER AND RECEIVED THE ON-Q PUMP. PATIENT REMOVED ON-Q PUMP ON (B)(6) 2021 WITHOUT ANY ISSUES BUT HER POST-OPERATIVE COURSE WAS COMPLICATED BY FEVERS AND PAIN AT THE PERIUMBILICAL REGION. SHE PLACED SEVERAL CALLS TO THE OFFICE REGARDING POST-OP PAIN CONCERNS. SHE HAD BEEN TAKING MOTRIN WITH SOME TYLENOL TO REDUCE FEVERS, BUT NOT TAKING NARCOTICS AS THEY MAKE HER FEEL WEEPY. SHE WAS PASSING FLATUS, HAVING BM [BOWEL MOVEMENTS], AND TOLERATING PO [ORAL INTAKE]. SHE WAS DIAGNOSED AND TREATED EMPIRICALLY WITH A UTI [URINA

  Patient problems: Abscess; Bacterial Infection; Cellulitis; Cramp(s) /Muscle Spasm(s); Distress; Dyspnea; Fever; Fungal Infection; Low Oxygen Saturation; Pain; Pulmonary Embolism; Respiratory Insufficiency; Sepsis; Tachycardia

  MAUDE report 11828799 ↗