Schon 10801701Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI H787108017010), received between Jun 9, 2017 and Dec 16, 2022 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 16, 2022Material Puncture/Hole; Material Puncture/Hole

  AN END USER EXPERIENCED AN ISSUE WHEN USING A SCHON XL 15CM. IT WAS REPORTED THAT WHEN A PATIENT WENT TO DIALYSIS FOR TREATMENT, THERE WERE HOLES NOTED IN THE DIALYSIS CATHETER. THE CATHETER IS PRESUMED TO HAVE BEEN REMOVED AND REPLACED IN ORDER FOR THE PATIENT TO CONTINUE DIALYSIS TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15996030 ↗
• MalfunctionDec 16, 2022Material Puncture/Hole; Material Puncture/Hole

  AN END USER EXPERIENCED AN ISSUE WHEN USING A SCHON XL 15CM. IT WAS REPORTED THAT WHEN A PATIENT WENT TO DIALYSIS FOR THEIR FIRST TREATMENT WHEN THE HOLES WERE FOUND. IT WAS REPORTED THE CATHETER HAD ONLY BEEN USED ONCE FOR HEMODIALYSIS. THE ISSUE WAS DISCOVERED UPON INITIAL USE. WHEN THE ISSUE WAS NOTICED, THE CATHETER WAS REMOVED AND REPLACED THAT SAME DAY. THERE WAS NO REPORT OF THE PATIENT EXPERIENCING ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15996001 ↗
• MalfunctionOct 11, 2021Fracture; Fracture

  AN END USER REPORTED AN ISSUE WITH A 14F X 15CM BASIC SCHON DIALYSIS CATHETER. POST PROCEDURE, THE SCHON CATHETER BROKE INTO 2 PIECES WHILE ON THE EXCHANGE WIRE, WHILE A NURSE PRACTITIONER WAS EXCHANGING THE SCHON TEMPORARY CATHETER INTO A TUNNELED PERMANENT CATHETER ( ROUTINE PRACTICE/PROCEDURE) IN THE INTERNAL JUGULAR VEIN USING A NITRIX GUIDEWIRE. THE DEVICE WAS REMOVED BY THE SURGEON, USING A SNARE, AND THE PCAD PERMANENT DEVICE WAS PLACED. THE PATIENT DID NOT EXPERIENCE ANY HARM OR ADVERSE EFFECTS AS A RESULT OF THIS INCIDENT. THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12605297 ↗
• MalfunctionSep 23, 2020Fluid/Blood Leak; Fluid/Blood Leak

  (1ST DEVICE/EVENT). AN END USER REPORTED AN ISSUE WITH A TEMPORARY, NON-TUNNELED 14F X 15CM BASIC SCHON CATHETER. THE PATIENT HAD THE CATHETER PLACED ON (B)(6) 2020; HOWEVER, AFTER SEVERAL MINUTES OF TREATMENT, BLOOD WAS NOTED TO BE DRIPPING FROM THE ARTERIAL PORT OF THE CATHETER. A PINPRICK SIZED HOLE WAS DISCOVERED. THE PATIENT REQUIRED REPLACEMENT OF THE CATHETER THE FOLLOWING DAY, ON (B)(6) 2020. WHEN THE PATIENT RETURNED FOR TREATMENT ON (B)(6) 2020, BLOOD WAS FOUND TO BE LEAKING AGAIN, EXCEPT FROM THE VENOUS PORT. A SMALL SLIT WAS DISCOVERED IN THE CATHETER LINE. THE PATIENT THEN HAD TO HAVE A 3RD CATHETER PLACED. IT WAS INDICATED THAT THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Fluid Discharge

  MAUDE report 10572739 ↗
• MalfunctionSep 23, 2020Fluid/Blood Leak; Fluid/Blood Leak

  (2ND DEVICE/EVENT) . AN END USER REPORTED AN ISSUE WITH A TEMPORARY, NON-TUNNELED 14F X 15CM BASIC SCHON CATHETER. THE PATIENT HAD THE CATHETER PLACED ON (B)(6) 2020, HOWEVER, AFTER SEVERAL MINUTES OF TREATMENT, BLOOD WAS NOTED TO BE DRIPPING FROM THE ARTERIAL PORT OF THE CATHETER. A PINPRICK SIZED HOLE WAS DISCOVERED. THE PATIENT REQUIRED REPLACEMENT OF THE CATHETER THE FOLLOWING DAY, ON (B)(6) 2020. WHEN THE PATIENT RETURNED FOR TREATMENT ON (B)(6) 2020, BLOOD WAS FOUND TO BE LEAKING AGAIN, EXCEPT FROM THE VENOUS PORT. A SMALL SLIT WAS DISCOVERED IN THE CATHETER LINE. THE PATIENT THEN HAD TO HAVE A 3RD CATHETER PLACED. IT WAS INDICATED THAT THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Fluid Discharge

  MAUDE report 10572738 ↗
• MalfunctionJun 9, 2017Leak/Splash; Leak/Splash

  AS REPORTED TO ANGIODYNAMICS ON (B)(6) 2016: TEMPORARY DIALYSIS CATHETER WAS PLACED ON PATIENT. BLUE PORT HAD A LEAK IN IT ON THE CLAMP PORTION OF THE LINE. THE PHYSICIAN ASSISTANT WAS ABLE TO ACCESS THE CATHETER AND PATIENT. PATIENT WAS ABLE TO COMPLETE THEIR APHERESIS WITH THE LEAK. THE CLAMP MAY HAVE CAUSED A PUNCTURE IN THE LINE. THE REPORTED DEFECTIVE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR AN INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6629740 ↗