Schon 10802702Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI H787108027020), received between Jan 24, 2023 and May 15, 2023 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT AFTER THE 4F X 20CM SCHON XL DOUBLE LUMEN CATHETER HAD BEEN IN SITU FOR ONE DAY, THE CATHETER WAS NOTED TO CONTAIN AIR BUBBLES. NO AIR BUBBLES HAD ENTERED THE PATIENT. THE CATHETER WAS REMOVED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16931801 ↗
• MalfunctionMar 14, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT AFTER THE 14F X 20CM SCHON XL DOUBLE LUMEN CATHETER HAD BEEN IN SITU FOR APPROXIMATELY 5 DAYS WHEN THE CATHETER WAS NOTED TO CONTAIN AIR BUBBLES. THERE WERE NOT ANY NOTICEABLE HOLES, PERFORATIONS, OR CRACKS IN THE TUBING. NO BUBBLES ENTERED THE PATIENT AS DIALYSIS WAS STOPPED WHEN THE BUBBLES WERE SEEN IN THE CATHETER. THE CATHETER WAS REMOVED AND REPLACED WITH A LONG-TERM CATHETER. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16538000 ↗
• MalfunctionFeb 6, 2023Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT WAS ON CRRT. LINES REVERSED. RIJ HD CATH. THE CRRT MACHINE BEGAN TO ALARM "FOAM DETECTED" AND IT STOPPED. THE PROVIDER ASSESSED THE LINES AND AIR WAS NOTED THROUGHOUT THE SYSTEM. WHEN EVALUATING THE SCHON CATHETER CONNECTIONS TO LINES EVERYTHING APPEARED INTACT, HOWEVER, UPON FURTHER INSPECTION THE ACCESS LINE (RED LINE) WAS CONNECTED TO BLUE PORT OF CATHETER AND THE CONNECTION WAS SLIGHTLY LOOSE. THERE WAS NO NOTED BLOOD LEAKING AROUND CONNECTION, BUT WAS NOTED TO BE THE SITE OF THE AIR ENTERING THE SYSTEM. THE DEVICE WAS REMOVED AND REPLACED THE NEXT DAY. THERE WAS NO REPORT OF THE PATIENT EXPERIENCING ANY ADVERSE EFFECTS OR HARM AS A RESULT OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16303203 ↗
• MalfunctionJan 24, 2023Material Puncture/Hole; Material Puncture/Hole

  A PHYSICIAN REPORTED AN ISSUE WITH A 14F X 20CM SCHON XL DOUBLE LUMEN CATHETER. DURING A DIALYSIS POST PROCEDURE ON FIRST HEMODIALYSIS RUN, A CRACK WAS DISCOVERED IN THE LINE NEAR THE HUB. THIS RESULTED IN AIR BEING DRAWN INTO THE CATHETER DURING TREATMENT; HOWEVER, THE AIR WAS CAUGHT IN THE AIR TRAP; THEREFORE, THE PATIENT WAS UNAFFECTED. THE PATIENT WAS ALREADY "INPATIENT" DURING THE INITIAL PROCEDURE AND THE SAME DAY, IT WAS REPORTED THE DEVICE WAS REMOVED AND THE PATIENT REQUIRED A REPEAT PROCEDURE FOR REPLACEMENT CATHETER. THE REPLACEMENT WAS WITH THE SAME STYLE SCHON LUMEN CATHETER. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16232723 ↗