SchonRecalls & reported problems across all models
Angiodynamics, Inc. · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 33
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 0
We found 7 models of Schon by Angiodynamics, Inc. in the FDA's device registry (GUDID). Together they are named in 33 adverse event reports in the FDA's MAUDE database, received between Apr 21, 2017 and May 15, 2023 — classified as 1 injury, 32 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (9 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Most reported Schon problems
Device problems
- Fluid/Blood Leak9
- Material Puncture/Hole8
- Leak/Splash6
- Detachment of Device or Device Component5
- Crack3
- Fracture2
- Adverse Event Without Identified Device or Use Problem1
- Difficult to Flush1
Patient problems
- No Clinical Signs, Symptoms or Conditions13
- No Known Impact Or Consequence To Patient12
- No Consequences Or Impact To Patient6
- Fluid Discharge2
- Hemorrhage/Blood Loss/Bleeding1
Schon models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Schon 10800701Catheter, hemodialysis, implanted9 reports
- Schon 10800702CATHETER, SUBCLAVIAN8 reports
- Schon 10801701Catheter, hemodialysis, implanted6 reports
- Schon 10802702CATHETER, HEMODIALYSIS, NON-IMPLANTED4 reports
- Schon 10800703CATHETER, SUBCLAVIAN3 reports
- Schon 10801703CATHETER, SUBCLAVIAN2 reports
- Schon 10801702Catheter, hemodialysis, implanted1 report
Recent Schon adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗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 ↗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 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 ↗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 ↗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 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 ↗MalfunctionDec 1, 2020Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
USER MEDWATCH (B)(4) RECEIVED DECEMBER 09, 2020. PER USER MEDWATCH RECEIVED: THE HEMODIALYSIS RN'S PROGRESS NOTES REPORTED THE HD CATHETER LEAK. THE PATIENT ARRIVED AT HDU FROM IR FOR A TEMPORTARY DIALYSIS PLACEMENT. HE WAS ALERT AND ORIENTED. HE DENIED ANY PAIN OR SHORTNESS OF BREATH (SOB). THE HD ORDERS WERE REVIEWED. (THE INTERVENTIONAL RADIOLOGY (IR) HAD PLACED A DOUBLE BALLOON PALINDROME CATHETER (UNEVENTFUL) . THE CATHERTER HAD BEEN FLUSHED WITH NO NOTED ISSUES. A NON-TUNNELED HD ON THE LEFT SC "OK TO USE" WAS CONFIRMED IN THE NOTES. BOTH LINES WERE GOOD TO PULL AND PUSH, NO LEAK NOTED. HD SYSTEM LINES WERE CONNECTED AS STANDARD MANNER, AND TX STARTED WITH QB 150, AND THEN SLOWLY INCREASED FOR ORDER 350. WHEN QB REACHED 300 ML/MIN, THE SHEET UNDERNEATH BECAME WET WITH BLOOD. CONNECTION WAS CHECKED AND IT WAS SECURE. CATHETER DRESSING REMAINED DRY. THE GAUZE PAD UNDER THE CATHETER LUMENS WERE WET WITH BLOOD AND A VISIBLE BLOOD LEAK WAS FOUND ON THE LUMEN ON V LINE ON THE CATHETER (BETWEEN CLAMP AND CONNECTION PART). THE HEMODIALYSIS NURSE STOPPED THE DIALYSIS TREATMENT AND CALLED IR. THE IR TEAM WENT TO THE PATIENT'S BEDSIDE IN DIALYSIS TO EXCHANGE THE CATHETER. THERE WAS NO R
Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions
MAUDE report 10927317 ↗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 ↗
Other Angiodynamics, Inc. products
- Soft-Vu54 models · 66 reports · 18 recalls
- Mini Stick MAX12 models · 2 reports · 12 recalls
- Smart Port CT36 models · 479 reports
- VenaCure EVLT15 models · 437 reports
- AccuVu9 models · 14 reports · 4 recalls
- DuraMax8 models · 23 reports · 3 recalls
- Solero4 models · 154 reports
- DuraFlow6 models · 8 reports · 2 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page