Schon 10801703Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI H787108017030), received between Jun 9, 2017 and Dec 1, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Crack” (1 report).

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 16, 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.

• MalfunctionDec 1, 2020Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  USER MEDWATCH (B)(4) RECEIVED DECEMBER 09, 2020. PER USER MEDWATCH RECEIVED: THE HEMODIALYSIS RN'S PROGRESS NOTES REPORTED THE HD CATHETER LEAK. THE PATIENT ARRIVED AT HDU FROM IR FOR A TEMPORTARY DIALYSIS PLACEMENT. HE WAS ALERT AND ORIENTED. HE DENIED ANY PAIN OR SHORTNESS OF BREATH (SOB). THE HD ORDERS WERE REVIEWED. (THE INTERVENTIONAL RADIOLOGY (IR) HAD PLACED A DOUBLE BALLOON PALINDROME CATHETER (UNEVENTFUL) . THE CATHERTER HAD BEEN FLUSHED WITH NO NOTED ISSUES. A NON-TUNNELED HD ON THE LEFT SC "OK TO USE" WAS CONFIRMED IN THE NOTES. BOTH LINES WERE GOOD TO PULL AND PUSH, NO LEAK NOTED. HD SYSTEM LINES WERE CONNECTED AS STANDARD MANNER, AND TX STARTED WITH QB 150, AND THEN SLOWLY INCREASED FOR ORDER 350. WHEN QB REACHED 300 ML/MIN, THE SHEET UNDERNEATH BECAME WET WITH BLOOD. CONNECTION WAS CHECKED AND IT WAS SECURE. CATHETER DRESSING REMAINED DRY. THE GAUZE PAD UNDER THE CATHETER LUMENS WERE WET WITH BLOOD AND A VISIBLE BLOOD LEAK WAS FOUND ON THE LUMEN ON V LINE ON THE CATHETER (BETWEEN CLAMP AND CONNECTION PART). THE HEMODIALYSIS NURSE STOPPED THE DIALYSIS TREATMENT AND CALLED IR. THE IR TEAM WENT TO THE PATIENT'S BEDSIDE IN DIALYSIS TO EXCHANGE THE CATHETER. THERE WAS NO R

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10927317 ↗
• MalfunctionJun 9, 2017Leak/Splash; Leak/Splash

  AS REPORTED TO ANGIODYNAMICS ON (B)(6) 2017: A SCHON XL CATHETER WAS PLACED IN A ICU PATIENT, AND IN THE SAME DAY, THE FLOOR NURSES NOTICED AIR BEING SUCKED INTO THE BLUE LUMEN. THEY PULLED THE CATHETER AND REPLACED IT WITH A NEW OF THE SAME DEVICE. THE REPORTED DEFECTIVE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR AN INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6629749 ↗