Schon 10800701Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI H787108007010), received between May 17, 2017 and Mar 21, 2022 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 21, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  A CRITICAL CARE SERVICES DIRECTOR REPORTED AN ISSUE WITH A 15CM SCHON XL DOUBLELUMEN CATHETER. APPROXIMATELY 2 HOURS AFTER PLACEMENT, THE BLUE, VENOUS PORT DETACHED FROM THE DEVICE. THE DEVICE WAS REMOVED AND REPLACED, WITH MINIMAL BLOOD LOSS. THE PATIENT DID HAVE A DELAY IN STARTING THEIR HEMODIALYSIS SLED PROCEDURE, BUT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM AS A RESULT OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13840068 ↗
• MalfunctionSep 15, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AN ANGIODYNAMICS TERRITORY MANAGER REPORTED AN ISSUE WITH A 15CM SCHON XL DOUBLE LUMEN CATHETER. IT WAS REPORTED THAT THE VENOUS LUMEN DETACHED FROM THE CATHETER, WHILE IMPLANTED IN THE PATIENT. THE PATIENT DAMAGED THE CATHETER WHILE SHE WAS IN HER ROOM CAUSING THE PATIENT TO LOOSE BLOOD. WHEN THE IR PA WENT TO BEDSIDE, THE HOSPITALIST AND 4 NURSES WERE HELPING THE PATIENT. THEY USED A HEMOSTAT TO STOP THE GUSHING BLOOD. THE CATHETER WAS REMOVED AND REPLACED AND THE PATIENT DID NOT REQUIRE ANY MEDICAL INTERVENTION AS A RESULT OF THE BLOOD LOSS. IT WAS INDICATED THE REPORTED DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12477031 ↗
• MalfunctionMay 10, 2021Fluid/Blood Leak; Fluid/Blood Leak

  AN ANGIODYNAMICS TERRITORY MANAGER REPORTED AN ISSUE WITH A 15CM SCHON XL DOUBLE LUMEN CATHETER. THREE DAYS AFTER THE CATHETER HAD BEEN PLACED IN THE PATIENT'S INTERNAL JUGULAR, BLOOD DROPLETS WERE NOTICED ON THE CATHETER EXTENSION TUBING. TREATMENT HAD NOT YET BEEN GIVEN VIA THE CATHETER. THE CATHETER WAS REMOVED AND REPLACED WITH ANOTHER SAME DEVICE. THERE WAS NO REPORT OF PATIENT HARM OR ADVERSE EVENT BY THE END USER. IT WAS INDICATED THAT THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11797126 ↗
• InjuryDec 10, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED: THE VASCATH WAS NOT FUNCTIONING PROPERLY. ONE OF THE PORTS BROKE AND THEY WERE NOT ABLE TO USE THE LINE. THE PATIENT HAD TO UNDERGO AN UNNECESSARY ADDITIONAL PROCEDURE TO REPLACE THE LINE WITH A NEW ONE. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9446441 ↗
• MalfunctionDec 10, 2019Crack; Crack

  AS REPORTED: CRACK AND LEAKING REPORTED IN THE INDWELLING CATHETER IMPLANTED ON (B)(6) 2019 BY DR (B)(6). 14FR DUAL LUMEN CENTRAL LINE ANGIODYNAMICS WHITE CATHETER SHON FOR HEMODIALYSIS. IT WAS REMOVED AND REPLACED BY DR (B)(6) ON (B)(6) 2019. NO HARM OR INJURY TO THE PATIENT DUE TO THIS EVENT. THE REPORTED DEFECTIVE DISPOSABLE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9446429 ↗
• MalfunctionDec 5, 2019Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED: 2 SCHON XL 15CM LENGTH DIALYSIS CATHETERS; BLUE HUBS CRACKED AND THERE WAS LEAKING WHEN INJECTING THROUGH THE HUB. THE TWO CATHETERS WERE IN SEPARATE PATIENTS. THEY WERE BOTH NEWLY PLACED AND EXCHANGED THAT DAY. THERE WASN'T ANY CLEANING AGENT USED AS THEY WERE JUST INITIALLY PLACED. ONE CATHETER WAS REPLACED WITH THE SAME AND THE SECOND WITH A 20CM. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9415538 ↗
• MalfunctionDec 5, 2019Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED: 2 SCHON XL 15CM LENGTH DIALYSIS CATHETERS; BLUE HUBS CRACKED AND THERE WAS LEAKING WHEN INJECTING THROUGH THE HUB. THE TWO CATHETERS WERE IN SEPARATE PATIENTS. THEY WERE BOTH NEWLY PLACED AND EXCHANGED THAT DAY. THERE WASN'T ANY CLEANING AGENT USED AS THEY WERE JUST INITIALLY PLACED. ONE CATHETER WAS REPLACED WITH THE SAME AND THE SECOND WITH A 20CM. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9415533 ↗
• MalfunctionJun 9, 2017Leak/Splash; Leak/Splash

  AS REPORTED TO ANGIODYNAMICS ON (B)(6) 2016: THE PATIENT'S CATHETER HAD A LEAK. IT IS A 24CM TEMP IN WHICH THE HOLE APPEARS EVIDENT IN THE CLEAR EXTENSION TUBING OF THE CATHETER AND WAS ONLY NOTICEABLE UPON PRESSURE INJECTION. THE REPORTED DEFECTIVE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR AN INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6629762 ↗
• MalfunctionMay 17, 2017Difficult to Flush; Adverse Event Without Identified Device or Use Problem; Difficult to Flush; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO ANGIODYNAMICS ON (B)(6) 2017: A PATIENT HAD A DIALYSIS CATHETER INSERTED WITH NO REPORT OF COMPLICATION OR DEVICE MALFUNCTION. POST PROCEDURE, THE SURGEON NOTED THE CATHETER DID NOT FUNCTION AS INTENDED. THE CATHETER WAS REMOVED AND REPLACED 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 6572953 ↗