Schon 10800702Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI H787108007020), received between Apr 21, 2017 and Apr 14, 2023 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2023Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IR PLACED A 14FX20CM SCHON XL DOUBLE LUMEN DIALYSIS CATHETER FOR HEMODIALYSIS. DURING USE, THE NURSE NOTICED ALARMS FOR AIR ON THE VENOUS LINE. THE SETUP WAS CHANGED, AND THE PROCEDURE WAS ATTEMPTED TO BE RESTARTED AGAIN, HOWEVER THE VENOUS LINE PORT TUBING HAD A SMALL HOLE ABOUT 1" FROM THE PORT WITH BLOOD DRIPPING OUT. THE NURSE STOPPED THE TREATMENT AND REPLACED THE CATHETER. THE TREATMENT WAS ABLE TO BE CONTINUED WITH NO FURTHER COMPLICATIONS. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM DUE TO THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16743232 ↗
• MalfunctionNov 13, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  DEVICE #2 AS REPORTED: (B)(6) SAID THE CATHETER WAS LEAKING UNDER THE HUB. TWO DEVICES HAD THE SAME ISSUE, BOTH HAD THE SAME LOT NUMBER AND UPN NUMBER. BOTH WERE USED ON THE SAME PATIENT. BOTH CATHETERS WERE REPLACED, THE SECOND DEFECTIVE CATHETER WAS REPLACED WITH A 24CM RATHER THAN A 20CM. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER AS IT WAS DISPOSED OF BY THE USER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9315229 ↗
• MalfunctionNov 13, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  DEVICE #1. AS REPORTED: (B)(6) SAID THE CATHETER WAS LEAKING UNDER THE HUB. TWO DEVICES HAD THE SAME ISSUE, BOTH HAD THE SAME LOT NUMBER AND UPN NUMBER. BOTH WERE USED ON THE SAME PATIENT. BOTH CATHETERS WERE REPLACED, THE SECOND DEFECTIVE CATHETER WAS REPLACED WITH A 24CM RATHER THAN A 20CM. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER AS IT WAS DISPOSED OF BY THE USER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9315197 ↗
• MalfunctionSep 26, 2019Crack; Crack

  AS REPORTED: WE PLACED A SCHON XL NON-TUNNELED CATHETER TODAY. IT ASPIRATED AND FLUSHED WITH NO ISSUE. PATIENT WAS SENT TO THE MAIN HOSPITAL TO COLLECT STEM CELLS. WHILE THERE, THE HUB OF THE CATHETER WAS BUBBLING; A SIGN OF AIR BEING ASPIRATED. A CRACK IN THE HUB WAS SUSPECTED, AND THE PATIENT WAS BROUGHT BACK FOR A CATHETER EXCHANGE. THE PATIENT SUFFERED NO HARM OR INJURY 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 9124786 ↗
• MalfunctionJul 31, 2018Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  AS REPORTED TO ANGIODYNAMICS ON (B)(6) 2018. DURING A DIALYSIS PROCEDURE, WHEN THE DIALYSIS INFUSANTS WERE ADMINISTERED, THE INFUSANTS LEAKED FROM A HOLE IN THE SIDE OF THE CATHETER OUTSIDE OF THE PATIENT. THE DEVICE WAS REMOVED AND REPLACED WITH A NEW OF THE SAME. THE REPORTED DEFECTIVE DISPOSABLE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7734947 ↗
• MalfunctionMay 10, 2017Fracture; Hole In Material; Fracture; Hole In Material

  AS REPORTED TO ANGIODYNAMICS ON APRIL 25, 2017 VIA A USER MEDWATCH MW5068931: DURING A DIALYSIS PROCEDURE, A HOLE IN THE PATIENT'S DIALYSIS CATHETER WAS NOTED. THE DEVICE WAS REMOVED AND REPLACED WITH A NEW OF THE SAME DEVICE. THERE WERE NO ADVERSE PATIENT EFFECTS DUE TO THIS EVENT. IT WAS REPORTED THAT THE DISPOSABLE DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. THE USER MEDWATCH DID NOT CONTAIN ANY IDENTIFYING COMPLAINANT CONTACT INFORMATION. A SEARCH OF THE PROVIDED LOT NUMBER REVEALED THE REPORTED LOT HAD BEEN SHIPPED TO MULTIPLE MEDICAL FACILITIES, THEREFORE ANGIODYNAMICS IS UNABLE TO IDENTIFY THE REPORTING COMPLAINANT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6556401 ↗
• MalfunctionApr 24, 2017Leak/Splash; Leak/Splash

  AS REPORTED TO ANGIODYNAMICS ON (B)(6) 2016: DURING A DIALYSIS PROCEDURE, IT WAS NOTED THE DIALYSIS CATHETER WAS LEAKING. THE CATHETER WAS REMOVED AND SET ASIDE. A NEW OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT SUFFERED NO HARM OR INJURY DUE TO THE EVENT. THE REPORTED DEFECTIVE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR AN INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6515244 ↗
• MalfunctionApr 21, 2017Leak/Splash; Leak/Splash

  AS REPORTED TO ANGIODYNAMICS ON JULY 25, 2016: DURING A DIALYSIS PROCEDURE, IT WAS NOTED THE DIALYSIS CATHETER WAS LEAKING. THE CATHETER WAS REMOVED AND DISCARDED. A NEW OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT SUFFERED NO HARM OR INJURY DUE TO THE EVENT. IT WAS REPORTED THAT THE DISPOSABLE DEVICE WAS DISCARDED BY THE USER AND IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6510583 ↗