Split Cath IIIRecalls & reported problems across all models
Medical Components, Inc. · 14 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 26
- Deaths reported
- 2
- Injuries reported
- 5
- Recalls
- 0
We found 14 models of Split Cath III by Medical Components, Inc. in the FDA's device registry (GUDID). Together they are named in 26 adverse event reports in the FDA's MAUDE database, received between Apr 11, 2017 and Mar 31, 2025 — classified as 2 deaths, 5 injuries, 19 malfunctions.
The most frequently reported specific device problem is “Disconnection” (8 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
Reports received per month, all models
Most reported Split Cath III problems
Device problems
- Disconnection8
- Break6
- Leak/Splash5
- Detachment of Device or Device Component2
- Connection Problem1
- Defective Component1
- Device Operates Differently Than Expected1
- Failure to Advance1
Patient problems
- No Known Impact Or Consequence To Patient9
- Blood Loss7
- No Clinical Signs, Symptoms or Conditions3
- Hemorrhage/Blood Loss/Bleeding2
- Chest Pain1
- Death1
- Device Embedded In Tissue or Plaque1
- Dyspnea1
Split Cath III models
14 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Split Cath® III ASPC18P-XLCatheter, hemodialysis, implanted4 reports
- Split Cath® III ASPC28-3E.Catheter, hemodialysis, implanted4 reports
- Split Cath® III ASPC32-3E.Catheter, hemodialysis, implanted4 reports
- Split Cath® III ASPC24P-XLCatheter, hemodialysis, implanted3 reports
- Split Cath® III ASPC24-3E.Catheter, hemodialysis, implanted2 reports
- Split Cath® III ASPC24-3Catheter, hemodialysis, implanted1 report
- Split Cath® III ASPC2416-3Catheter, hemodialysis, implanted1 report
- SPLIT CATH® III ASPC28-3PCE.Catheter, hemodialysis, implanted1 report
- Split Cath® III ASPC32-3Catheter, hemodialysis, implanted1 report
- SPLIT CATH® III ASPC36-3PCE.Catheter, hemodialysis, implanted1 death1 report
- Split Cath® III ASPC40-3Catheter, hemodialysis, implanted1 death1 report
- Split Cath® III ASPC40-3E.Catheter, hemodialysis, implanted1 report
- Split Cath® III RMS23602Catheter, hemodialysis, implanted1 report
- Split Cath® III TRAY 3216-3Catheter, hemodialysis, implanted1 report
Recent Split Cath III adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 31, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AS RN WAS CLEANING PT'S CATHETER BEFORE TX, BOTH LUMEN TIPS (LUERS) BECAME DETACHED. RN PLACED BOTH TIPS BACK INTO CATHETER, PROCEEDED WITH TX AS NORMAL. THE CATHETER DID STAY INTACT DURING AND AFTER DIALYSIS TX, PER PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21729638 ↗MalfunctionOct 24, 2022Break; Break
EXTENSION TUBING TORN AT THE HUB.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15657567 ↗DeathMay 3, 2022Disconnection; Disconnection
DURING TREATMENT, THE PATIENT WAS FOUND UNRESPONSIVE, PALE & UNABLE TO OBTAIN A BLOOD PRESSURE. WAS NOTED THAT UPON MOVING CLOTHES TO REVIEW CENTRAL VENOUS TUNNELLED DIALYSIS CATHETER (TCVC) THAT THE VENOUS LINE CONNECTION HAD BECOME DETACHED AND THERE WAS AN ACCUMULATION OF BLOOD BOTH ON FLOOR AND UNDER CLIENT, AND UNFORTUNATELY THE PATIENT PASSED AWAY.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 14269706 ↗MalfunctionApr 8, 2022Disconnection; Disconnection
WHEN DISCONNECTING THE CATHETER, AFTER TO UNSCREW THE LINE, THE VENOUS LINE HAS BEEN "SECTIONED".
Patient problems: Insufficient Information
MAUDE report 14052177 ↗MalfunctionMay 13, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
THE 2.5 FLOW PERMCATH CATHETER WAS USED FOR CONTRAST INJECTION. IN THE BLUE LUER IT WAS USED WITH A 3-WAY FAUCET, SINCE THE RED ROUTE RECEIVED SALINE SOLUTION. THE RED LUER WAS CLOSED AND THE BLUE LUER WAS OPENED, THE TAP WAS TURNED ON AT THE CONNECTION. WHEN PERFORMING THE TEST WITH SERUM IN THE INJECTOR WITH FLOW 2.5, THE TAPS AND THE WHITE PART OF THE CATHETER CAME OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11819788 ↗MalfunctionJul 22, 2020Improper Flow or Infusion; Improper Flow or Infusion
POSSIBLE FISTULA WITHIN LINE PROBLEMS WITH LOW VENOUS PRESSURE ON HD MACHINE. PARENTS SAW TINY AIR BUBBLE GO IN THROUGH BLUE LUMEN AND COME STRAIGHT OUT THE RED LUMEN. ALSO, BLOOD SHOULD COME OUT OF THE ARTERIAL LUMEN VERY DARK AS IT SHOULD HAVE HAD NO MIXTURE WITH SALINE HOWEVER USING THIS LINE THE BLOOD CAME OUT THE ARTERIAL LUMEN VERY OBVIOUSLY MIXED WITH SALINE. THOUGHT TO BE SOME COMMUNICATION BETWEEN ARTERIAL LUMEN AND VENOUS LUMEN WITHIN THE LINE ITSELF.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10308201 ↗MalfunctionMar 16, 2020Leak/Splash; Leak/Splash
AFTER HAVING CONNECTED THE PATIENT AIR BUBBLE ALARM FROM THE DIALYSIS MACHINE. LOTS OF BUBBLES ON THE ARTERIAL EXTENSION. TREATMENT INTERRUPTION IN ORDER TO CHECK THE LUER LOCK CONNECTION: OK NO ISSUE. TREATMENT CONTINUITY BUT NEW AIR BUBBLE ALARM. VISUALLY, AIR BUBBLES WERE DRAWN DIRECTLY INTO THE ARTERIAL EXTENSION. TREATMENT INTERRUPTION: LINE DISCONNECTION, RINSING WITH WATER, INSERTION OF TIPS. VISUALLY, BLOOD WAS FLOWING SLIGHTLY BETWEEN THE LUMEN AND THE EXTENSION ADAPTOR. REMOVAL OF THE CATHETER THEN INSERTION OF A NEW. THE CATHETER SEEMS TO HAVE A TEAR. THE PATIENT IS NOW IN GOOD CONDITION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9836862 ↗MalfunctionDec 5, 2019Disconnection; Disconnection
DURING DIALYSIS, "THE TUBING CONNECTION BECAME UNSECURE FROM THE LUMEN OF DIALYSIS CATHETER".
Patient problems: No Information
MAUDE report 9415469 ↗MalfunctionAug 22, 2019Leak/Splash; Leak/Splash
AFTER BEING IMPLANTED FOR APPROXIMATELY 12 MONTHS, THE LUMEN OF THE CATHETER WAS NOTED TO BALLOON. A SLICE/CUT APPEARS ON A PORTION OF THE LUMEN WHICH WAS UNDER A GAUZE DRESSING. THE BALLOONING WAS REPORTED TO OCCUR AFTER THE CATHETER WAS CLAMPED TO BLOCK THE BLOOD FROM LEAKING OUT FROM THE SLICE. THE CATHETER WAS USED ONLY FOR DIALYSIS AND WAS NOT USED FOR POWER INJECTIONS. CATHETER WAS REMOVED.
Patient problems: Blood Loss
MAUDE report 8921139 ↗InjuryAug 20, 2019Break; Break
TUNNELED HEMODIALYSIS CATHETER WAS NOTED AS HAVING PROBLEMS WITH FLOW DURING DIALYSIS SESSIONS SO THE RENAL TEAM ASKED THAT IT BE REMOVED. THE CATHETER WAS REMOVED SUCCESSFULLY AT THE BEDSIDE. HOWEVER, A FOREIGN BODY OF THE CHEST WALL WAS NOTED AFTER THE REMOVAL. PATIENT WAS TRANSFERRED TO THE SEDATION AREA WHERE A SINGLE PIECE OF OPAQUE WHITE PLASTIC TUBING, CONSISTENT WITH HEMODIALYSIS CATHETER, WAS REMOVED
Patient problems: Device Embedded In Tissue or Plaque; Renal Failure
MAUDE report 8909784 ↗MalfunctionJul 11, 2019Disconnection; Disconnection
CATHETER WAS PLACED ON (B)(6) 2019. THE WING, ALLOWING THE CATHETER TO BE HELD BY WIRES, WAS DISCONNECTED. THE WING REMAINED ATTACHED TO THE WIRES AND THE CATHETER CAME OUT. THE CATHETER WAS TORN OFF BY THE PATIENT ON (B)(6) 2019, AFTER THE CATHETER DISCONNECTED FROM THE WING.
Patient problems: Blood Loss
MAUDE report 8781790 ↗InjuryJul 1, 2019Break; Break
DIALYSIS INITIATED USING THE PATIENT'S AVF. THE VENOUS NEEDLE INFILTRATED AND THE DIALYSIS TREATMENT WAS CONVERTED TO USING THE PATIENT'S RIGHT INTERNAL JUGULAR CATHETER, IT WAS NOTED THE ARTERIAL RED CLAMP WAS CRACKED AND UNABLE TO BE CLAMPED. DIALYSIS TREATMENT WAS TERMINATED, CATHETER PORTS FLUSHED AND CAPPED. UPON PATIENT AMBULATING TO SCALE PATIENT BEGAN COUGHING, COMPLAINED OF SHORTNESS OF BREATH AND SEVERE CHEST PAIN. 911 WAS CALLED. PATIENT WAS TRANSPORTED TO THE HOSPITAL AND ADMITTED. PATIENT WAS DISCHARGED FROM THE HOSPITAL 3 DAYS LATER.
Patient problems: Chest Pain; Dyspnea
MAUDE report 8750272 ↗MalfunctionMay 8, 2019Fracture; Fracture
A NEW CATHETER DRESSING WAS APPLIED AND THE CATHETER WAS TESTED. AIR BUBBLES WERE PRESENT WHEN SUCTIONING THE VENOUS BRANCH. A CRACK WAS NOTED JUST BELOW THE SUTURE WINGS. PATIENT WAS HOSPITALIZED, THE SPLIT CATH WAS REMOVED AND A FEMORAL CATHETER WAS INSERTED. PATIENT IS CHRONICALLY DIALYZED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8591340 ↗MalfunctionJan 4, 2019Leak/Splash; Leak/Splash
WHEN CONNECTING THE PATIENT, AIR WAS INSIDE THE 2 CATHETER BRANCHES. THE DIALYSIS SESSION WAS IMMEDIATELY STOPPED AND THE DOCTORS WERE CALLED. BLOOD PRESENCE WAS ON THE DRESSING. WITH A VISUAL INSPECTION, IT WAS NOTICED A CUT BETWEEN THE TRIANGLE AND THE CATHETER PART ON THE PATIENT SIDE. THE CATHETER WAS REMOVED BY THE DOCTOR. NO CLINICAL CONSEQUENCES FOR THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8217626 ↗MalfunctionJan 3, 2019Leak/Splash; Leak/Splash
Other Medical Components, Inc. products
All Medical Components, Inc. devices →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.
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