Schon 10800703Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI H787108007030), received between Jul 31, 2018 and Oct 20, 2022 — classified as 3 malfunctions.

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

• MalfunctionOct 20, 2022Material Puncture/Hole; Material Puncture/Hole

  A RISK MANAGER REPORTED AN ISSUE WITH A 24CM SCHON XL DOUBLE LUMEN CATHETER. IT WAS REPORTED THAT THE DEVICE REQUIRED REPLACEMENT DUE TO A HOLE IN THE BLUE PORT CATHETER/EXTENSION LEG. THE ORIGINAL CATHETER WAS PLACED AND HEPARINIZED. IR DID NOT RECOGNIZE THE LEAK BUT IT WAS REPORTED THEY BARELY HAD THE CATHETER UN-CLAMPED FOR ANY LONG LENGTH OF TIME. DIALYSIS TREATMENT WAS STARTED, AND A HOLE WAS NOTED DURING ASPIRATION AND FLUSHING, WHICH RESULTED IN A LEAK IN BLUE PORT. IR WAS NOTIFIED AND THE CATHETER WAS EXCHANGED. 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 15638252 ↗
• MalfunctionAug 22, 2018Material Puncture/Hole; Material Puncture/Hole

  AS REPORTED TO ANGIODYNAMICS ON (B)(6) 2018: A PATIENT HAD A SCHON XL PLACED THAT AND REMOVED LATER THE NEXT DAY DUE TO A CATHETER FRACTURE. THE PORT HAS BEEN INDWELLING FOR 1 DAY. THE CATHETER WAS SAID TO HAVE BEEN A PIN-HOLE LEAK AT THE Y SITE CLEAR TUBING. UPON PICKING UP THE CATHETER TO HAVE SENT IN (RETURNED TO THE MANUFACTURER) IT WAS NOTED THAT THE PIECE WAS COMPLETELY REMOVED FROM THE Y-SITE. THERE WAS 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 7804413 ↗
• MalfunctionJul 31, 2018Unsealed Device Packaging; Unsealed Device Packaging

  AS REPORTED TO ANGIODYNAMICS ON (B)(6) 2018: WHEN 24CM SCHON XL WAS PULLED TO BE USED ON A PATIENT IT WAS DISCOVERED THAT THE PACKAGING WAS NOT FULLY SEALED RENDERING THE DEVICE NON STERILE. DEVICE AND PACKAGING WERE DISPOSED OF.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7734957 ↗