HemoSplit Long-Term Hemodialysis CatheterRecalls & reported problems across all models
Bard Access Systems, Inc. · 18 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 309
- Deaths reported
- 7
- Injuries reported
- 26
- Recalls
- 0
We found 18 models of HemoSplit Long-Term Hemodialysis Catheter by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 309 adverse event reports in the FDA's MAUDE database, received between Oct 30, 2015 and Sep 23, 2026 — classified as 7 deaths, 26 injuries, 276 malfunctions.
The most frequently reported specific device problem is “Fracture” (78 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 HemoSplit Long-Term Hemodialysis Catheter problems
Device problems
- Fracture78
- Fluid/Blood Leak44
- Deformation Due to Compressive Stress38
- Material Deformation27
- Break19
- Defective Component19
- Material Separation19
- Restricted Flow rate18
Patient problems
- No Clinical Signs, Symptoms or Conditions186
- No Consequences Or Impact To Patient58
- No Known Impact Or Consequence To Patient23
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available14
- Injury8
- No Patient Involvement8
- Thrombosis/Thrombus4
- Bacterial Infection2
HemoSplit Long-Term Hemodialysis Catheter models
18 models, most reported first. Each model has its own page with its reports, recalls and device details.
- HemoSplit Long-Term Hemodialysis Catheter 5733690Catheter, hemodialysis, implanted81 reports
- HemoSplit Long-Term Hemodialysis Catheter 5733730Catheter, hemodialysis, implanted1 death63 reports
- HemoSplit Long-Term Hemodialysis Catheter 5743690Catheter, hemodialysis, implanted50 reports
- HemoSplit Long-Term Hemodialysis Catheter 5743730Catheter, hemodialysis, implanted27 reports
- HemoSplit Long-Term Hemodialysis Catheter 5703690Catheter, hemodialysis, implanted21 reports
- HemoSplit Long-Term Hemodialysis Catheter 5735190Catheter, hemodialysis, implanted3 deaths16 reports
- HemoSplit Long-Term Hemodialysis Catheter 5733270Catheter, hemodialysis, implanted1 death14 reports
- HemoSplit Long-Term Hemodialysis Catheter 5735150Catheter, hemodialysis, implanted9 reports
- HemoSplit Long-Term Hemodialysis Catheter 5704190Catheter, hemodialysis, implanted5 reports
- HemoSplit Long-Term Hemodialysis Catheter 5703730Catheter, hemodialysis, implanted4 reports
- HemoSplit Long-Term Hemodialysis Catheter 5704150Catheter, hemodialysis, implanted4 reports
- HemoSplit Long-Term Hemodialysis Catheter 5734420Catheter, hemodialysis, implanted4 reports
- HemoSplit Long-Term Hemodialysis Catheter 5743270Catheter, hemodialysis, implanted4 reports
- HemoSplit Long-Term Hemodialysis Catheter 5733694Catheter, hemodialysis, implanted2 deaths2 reports
- HemoSplit Long-Term Hemodialysis Catheter 5733734Catheter, hemodialysis, implanted2 reports
- HemoSplit Long-Term Hemodialysis Catheter 5733274Catheter, hemodialysis, implanted1 report
- HemoSplit Long-Term Hemodialysis Catheter 5733350Catheter, hemodialysis, implanted1 report
- HemoSplit Long-Term Hemodialysis Catheter 5735230Catheter, hemodialysis, implanted1 report
Recent HemoSplit Long-Term Hemodialysis Catheter adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Fracture
On (b)(6) 2026, a patient underwent a catheter placement procedure through the right internal jugular vein using a HemoSplit Hemodialysis Catheter. During the procedure, angiography confirmed that the guidewire was properly positioned. While inserting the new catheter, a fractured catheter tip was observed. The procedure was subsequently completed using another device. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50865161 ↗InjuryAug 5, 2026Improper or Incorrect Procedure or Method
It has been reported that the patient underwent placement of a HemoSplit Hemodialysis Catheter on (b)(6)2026, at (b)(6). Following insertion, it was determined that the right sided dialysis catheter had been inadvertently inserted through both walls of the internal jugular vein into the mediastinum. The patient was transferred to (b)(6) ) for further management and catheter removal. On (b)(6) 2026, the patient was admitted to the Cardiothoracic Critical Care Unit (CTCCU). The misplaced catheter was removed in a hybrid theatre/angiography suite using guidewire-assisted removal with balloon tamponade. The removal procedure was uneventful, and a new left-sided dialysis catheter was subsequently inserted. Following intubation for the catheter removal procedure, the patient developed type II respiratory failure and required prolonged mechanical ventilation in CTCCU. After extubation, the patient experienced new-onset expressive dysphasia and left upper limb weakness, requiring re-intubation. A CT scan performed on (b)(6) 2026, demonstrated pre-existing cerebral infarcts and no evidence of intracranial hemorrhage. The patient was transferred back to (b)(6) on (b)(6) 2026 and remained ven
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Dysphasia; Respiratory Failure
MAUDE report 50137649 ↗MalfunctionMay 8, 2026Fracture
ON (B)(6) 2026, A PATIENT UNDERWENT A CATHETER PLACEMENT PROCEDURE USING THE HEMOSPLIT CATHETER. DURING USE, THE SHEATH TORE WITH THE OPENING OF THE TUBING RUPTURING SPONTANEOUSLY BEFORE IT WAS INTENTIONALLY TORN OPEN. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25121584 ↗MalfunctionMay 4, 2026Deformation Due to Compressive Stress
ON (B)(6) 2026, A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING THE HEMOSPLIT HEMODIALYSIS CATHETER. DURING THE PROCEDURE, THE FRONT END OF THE CATHETER WAS FOUND TO BE BENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25067222 ↗InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem
THE PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING THE HEMOSPLIT HEMODIALYSIS CATHETER. DURING THE PROCEDURE, A SERIOUS ADVERSE EVENT RELATED TO THE PROCEDURE WAS REPORTED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25025557 ↗InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem
THE PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING THE HEMOSPLIT HEMODIALYSIS CATHETER. DURING THE PROCEDURE, A SERIOUS ADVERSE EVENT RELATED TO THE PROCEDURE WAS REPORTED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25025389 ↗DeathApr 29, 2026Deformation Due to Compressive Stress
ON (B)(6), 2026, A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE WITH USE OF A HEMOSPLIT HEMODIALYSIS CATHETER INTO THE RIGHT INTERNAL JUGULAR VEIN. THE VENOUS PUNCTURE AND CATHETERIZATION WERE COMPLETED WITHOUT ISSUE; HOWEVER, AFTER THE CATHETER WAS ADVANCED THROUGH THE SUBCUTANEOUS TUNNEL AND INTO THE PUNCTURED JUGULAR VEIN, THE CLINICIAN ENCOUNTERED DIFFICULTY PROGRESSING THE DEVICE THROUGH THE SUPERIOR VENA CAVA DUE TO THE DEVICE'S CURVATURE AND RIGIDITY. UNDER FLUOROSCOPY, THE CATHETER TIP WAS NOTED TO BE KINKED AT THE SUPERIOR VENA CAVA RIGHT ATRIUM JUNCTION. IT WAS NOT POSSIBLE TO STRAIGHTEN THE CATHETER USING A GUIDEWIRE THAT WAS INSERTED INTO THE LUMENS. AFTER ATTEMPTING TO COMPLETELY REMOVE THE CATHETER, THE PATIENT SUFFERED A TRAUMATIC TEAR OF THE RIGHT ATRIUM REPORTEDLY DUE TO THE RIGID CATHETER. THE PATIENT SUBSEQUENTLY DEVELOPED A THROMBOSIS OF THE SUPERIOR VENA CAVA WITH ACUTE TAMPONADE. THE PATIENT WENT INTO CARDIAC ARREST AND REPORTEDLY EXPIRED.
Patient problems: Cardiac Arrest; Cardiac Tamponade; Thrombosis/Thrombus
MAUDE report 25024620 ↗MalfunctionApr 16, 2026Fracture
THE CUSTOMER REPORTED THAT ON MAR 23, 2026, THE HEMOSPLIT HEMODIALYSIS CATHETER IS FUNCTIONING PROPERLY, BUT ONE OF THE CLAMPS IS CRACKED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24902190 ↗MalfunctionApr 8, 2026Fluid/Blood Leak; Material Puncture/Hole
ON (B)(6) 2026, A PATIENT WAS PREPPED FOR A DIALYSIS CATHETER PLACEMENT PROCEDURE USING THE HEMOSPLIT HEMODIALYSIS CATHETER. DURING THE PREPARATION, A PINHOLE WAS FOUND IN THE ARTERIAL SEGMENT OF THE Y TUBE AND ALLEGEDLY LEAKED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24813195 ↗MalfunctionApr 2, 2026Fluid/Blood Leak
ON (B)(6) , 2025, A PATIENT PREPPED FOR A DIALYSIS CATHETER PLACEMENT PROCEDURE USING THE HEMOSPLIT HEMODIALYSIS CATHETER. PRIOR TO THE PROCEDURE, DURING PREPARATION, LEAKAGE WAS DISCOVERED IN THE COMPONENTS. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24762514 ↗InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem
ON (B)(6) , 2026, A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING HEMOSPLIT HEMODIALYSIS CATHETER. DURING THE PROCEDURE, A SERIOUS ADVERSE EVENT RELATED TO THE PROCEDURE WAS REPORTED. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. THIS IS REPORT 3 OF 13.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24678404 ↗InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem
ON (B)(6) , 2026, A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING HEMOSPLIT HEMODIALYSIS CATHETER. DURING THE PROCEDURE, A SERIOUS ADVERSE EVENT RELATED TO THE PROCEDURE WAS REPORTED. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. THIS IS REPORT 8 OF 13.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24671730 ↗InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2026, A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING HEMOSPLIT HEMODIALYSIS CATHETER. DURING THE PROCEDURE, A SERIOUS ADVERSE EVENT RELATED TO THE PROCEDURE WAS REPORTED. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. THIS IS REPORT 12 OF 13.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24671729 ↗InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem
ON (b)(6) 2026, A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING HEMOSPLIT HEMODIALYSIS CATHETER. DURING THE PROCEDURE, A SERIOUS ADVERSE EVENT RELATED TO THE PROCEDURE WAS REPORTED. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.THIS IS REPORT 2 OF 13.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24671726 ↗DeathMar 23, 2026Material Too Rigid or Stiff; Failure to Advance
ON (B)(6) 2026, A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE WITH USE OF A HEMOSPLIT HEMODIALYSIS CATHETER IN TO THE RIGHT INTERNAL JUGULAR VEIN. THE VENOUS PUNCTURE AND CATHETERIZATION WERE COMPLETED WITHOUT ISSUE; HOWEVER AFTER THE CATHETER WAS ADVANCED THROUGH THE SUBCUTANEOUS TUNNEL AND INTO THE PUNCTURED JUGULAR VEIN, THE CLINICIAN ENCOUNTERED DIFFICULTY PROGRESSING THE DEVICE THROUGH THE SUPERIOR VENA CAVA DUE TO THE DEVICE'S CURVATURE AND RIGIDITY. UNDER FLUOROSCOPY, THE CATHETER TIP WAS NOTED TO BE KINKED AT THE SUPERIOR VENA CAVA RIGHT ATRIUM JUNCTION. IT WAS NOT POSSIBLE TO STRAIGHTEN THE CATHETER USING A GUIDEWIRE THAT WAS INSERTED INTO THE LUMENS. AFTER ATTEMPTING TO COMPLETELY REMOVE THE CATHETER, THE PATIENT SUFFERED A TRAUMATIC TEAR OF THE RIGHT ATRIUM REPORTEDLY DUE TO THE RIGID CATHETER. THE PATIENT SUBSEQUENTLY DEVELOPED A THROMBOSIS OF THE SUPERIOR VENA CAVA WITH ACUTE TAMPONADE. THE PATIENT WENT INTO CARDIAC ARREST AND REPORTEDLY EXPIRED.
Patient problems: Cardiac Perforation; Cardiac Tamponade; Thrombosis/Thrombus
MAUDE report 24659469 ↗
Other Bard Access Systems, Inc. products
- Port Access Needle122 models · 3,744 reports · 3 recalls
- Groshong NXT ClearVue Catheter8 models · 3,266 reports
- PowerPort ClearVUE27 models · 1,993 reports · 15 recalls
- Site~Rite 8 Ultrasound System11 models · 1,965 reports
- PowerPort M.R.I., ChronoFlex22 models · 1,642 reports · 1 recall
- PowerPICC Provena116 models · 1,337 reports · 2 recalls
- PowerPort M.R.I., Groshong10 models · 1,285 reports
- Navarre15 models · 1,228 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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