HemoStar Long-Term Hemodialysis CatheterRecalls & reported problems across all models
Bard Access Systems, Inc. · 13 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 527
- Deaths reported
- 4
- Injuries reported
- 39
- Recalls
- 0
We found 13 models of HemoStar Long-Term Hemodialysis Catheter by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 527 adverse event reports in the FDA's MAUDE database, received between Jan 21, 2016 and Sep 29, 2026 — classified as 4 deaths, 39 injuries, 484 malfunctions.
The most frequently reported specific device problem is “Fracture” (131 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 HemoStar Long-Term Hemodialysis Catheter problems
Device problems
- Fracture131
- Fluid/Blood Leak90
- Material Deformation74
- Material Opacification54
- Stretched41
- Suction Problem40
- Air/Gas in Device37
- Deformation Due to Compressive Stress34
Patient problems
- No Clinical Signs, Symptoms or Conditions289
- No Consequences Or Impact To Patient110
- No Known Impact Or Consequence To Patient44
- No Patient Involvement36
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available14
- Hemorrhage/Blood Loss/Bleeding12
- Fever6
- Injury5
HemoStar Long-Term Hemodialysis Catheter models
13 models, most reported first. Each model has its own page with its reports, recalls and device details.
- HemoStar Long-Term Hemodialysis Catheter 5833690Catheter, hemodialysis, implanted2 deaths290 reports
- HemoStar Long-Term Hemodialysis Catheter 5833730Catheter, hemodialysis, implanted1 death141 reports
- HemoStar Long-Term Hemodialysis Catheter 5833350Catheter, hemodialysis, implanted21 reports
- HemoStar Long-Term Hemodialysis Catheter 5834190Catheter, hemodialysis, implanted20 reports
- HemoStar Long-Term Hemodialysis Catheter 5835190Catheter, hemodialysis, implanted15 reports
- HemoStar Long-Term Hemodialysis Catheter 5833270Catheter, hemodialysis, implanted10 reports
- HemoStar Long-Term Hemodialysis Catheter 5834150Catheter, hemodialysis, implanted7 reports
- HemoStar Long-Term Hemodialysis Catheter 5835150Catheter, hemodialysis, implanted6 reports
- HemoStar Long-Term Hemodialysis Catheter 5834420Catheter, hemodialysis, implanted5 reports
- HemoStar Long-Term Hemodialysis Catheter 5833150Catheter, hemodialysis, implanted4 reports
- HemoStar Long-Term Hemodialysis Catheter 5835230Catheter, hemodialysis, implanted4 reports
- HemoStar Long-Term Hemodialysis Catheter 5834230Catheter, hemodialysis, implanted3 reports
- HemoStar Long-Term Hemodialysis Catheter 5835270Catheter, hemodialysis, implanted1 death1 report
Recent HemoStar 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 29, 2026Fluid/Blood Leak
On (b)(6) 2026, a patient was prepared for a dialysis catheter placement procedure using a HemoStar Hemodialysis Catheter. Prior to patient use, during device preparation, the physician inspected the product's outer packaging and observed no abnormalities. After opening the catheter package and flushing the introducer needle and catheter with saline, fluid leakage was observed from the introducer needle. The device was not used on the patient, and the procedure was subsequently completed using another device. There was no reported patient contact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50928109 ↗DeathJun 4, 2026Fluid/Blood Leak; Fracture
ON (B)(6) 2024, A PATIENT UNDERWENT CATHETERIZATION INTO THE RIGHT INTERNAL JUGULAR VEIN USING THE HEMOSTAR HEMODIALYSIS CATHETER. ON (B)(6) 2024, THE PATIENT EXPERIENCED A RUPTURE OF THE DIALYSIS CATHETER WHILE AT HOME. EMERGENCY RESPONDERS APPLIED PRESSURE TO THE TUBING AND TRANSFERRED THE PATIENT TO THE HOSPITAL AND DIAGNOSED WITH ACUTE RESPIRATORY FAILURE AND HEMORRHAGIC SHOCK. THE PATIENT WENT INTO CARDIAC ARREST AND CPR WAS PERFORMED. DESPITE RESUSCITATION EFFORTS, THE PATIENT SUBSEQUENTLY EXPIRED.
Patient problems: Cardiac Arrest; Hypovolemic Shock
MAUDE report 25390370 ↗MalfunctionJun 4, 2026Material Opacification
ON (B)(6) 2025, A PATIENT UNDERWENT DIALYSIS CATHETER PLACEMENT PROCEDURE USING HEMOSTAR HEMODIALYSIS CATHETER. AFTER SOME TIME, ON (B)(6) 2026, IT WAS NOTED THAT THE CATHETER CONNECTING SEGMENT APPEARED TO BE SEVERELY EMULSIFIED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25388471 ↗MalfunctionMay 25, 2026Suction Problem; Air/Gas in Device
ON (B)(6) 2026, A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING THE HEMOSTAR HEMODIALYSIS CATHETER. DURING THE PROCEDURE, AIR ALLEGEDLY LEAKED IN THE SYRINGE NEEDLE AND BLOOD COULD NOT BE WITHDRAWN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25269301 ↗MalfunctionMay 15, 2026Fluid/Blood Leak; Fracture; Air/Gas in Device
ON (B)(6) 2026, A PATIENT UNDERWENT A DIALYSIS CATHETER IMPLANTATION USING HEMOSTAR HEMODIALYSIS CATHETER. DURING PROCEDURE FOR A PATIENT WITH CHRONIC RENAL FAILURE IN THE UREMIC STAGE, THE CATHETER KIT WAS INSPECTED PREOPERATIVELY AND CONFIRMED TO BE WITHIN ITS VALIDITY PERIOD. PUNCTURE OF THE INTERNAL JUGULAR VEIN WAS SUCCESSFUL WITH FLUENT VENOUS BLOOD RETURN. HOWEVER, A LARGE NUMBER OF AIR BUBBLES WERE OBSERVED DURING ASPIRATION. TROUBLESHOOTING MEASURES, INCLUDING REPLACEMENT OF OTHER CONSUMABLES SUCH AS SYRINGES, DID NOT RESOLVE THE ISSUE, AND THE SOURCE OF THE AIR BUBBLES WAS ATTRIBUTED TO THE CATHETER KIT, PROMPTING IMMEDIATE DISCONTINUATION OF ITS USE. THE CATHETER TUBING WAS REPLACED WITH A NEW ONE, ALLOWING THE PROCEDURE TO BE COMPLETED WITHOUT ANY KNOWN PATIENT HARM. POSTOPERATIVELY, LEAKAGE WAS NOTED FROM THE PLASTIC COMPONENT WHEN THE INTRODUCER NEEDLE EYE'S FURTHER INSPECTION REVEALED AN IMPERCEPTIBLE CRACK IN THE INTRODUCER NEEDLE, CONFIRMING IT AS THE CAUSE OF THE INTRAOPERATIVE AIR BUBBLES. THE DAMAGED INTRODUCER NEEDLE WAS SUBSEQUENTLY SEALED AND LABELED AS "DAMAGED" IN ACCORDANCE WITH MEDICAL WASTE CLASSIFICATION REQUIREMENTS. THERE WAS NO REPORTED PATIENT INJUR
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25179902 ↗MalfunctionMay 12, 2026Failure to Advance; Deformation Due to Compressive Stress
ON (B)(6) 2026, A PATIENT UNDERWENT A RIGHT INTERNAL JUGULAR VEIN LONG TERM HEMODIALYSIS CATHETER PLACEMENT USING THE HEMOSTAR. PRE OPERATIVE INSPECTION CONFIRMED THE DIALYSIS CATHETER PACKAGE WAS INTACT AND WITHIN EXPIRATION. DURING THE PROCEDURE, VENOUS PUNCTURE WAS SUCCESSFULLY PERFORMED WITH SMOOTH BLOOD RETURN HOWEVER, AFTER PLACEMENT, THE GUIDEWIRE COULD NOT BE ADVANCED INTO THE VESSEL, AND SLIGHT DEFORMATION OF THE GUIDEWIRE WAS OBSERVED UPON WITHDRAWAL. A SECOND PUNCTURE ATTEMPT WAS MADE, BUT THE GUIDEWIRE AGAIN COULD NOT BE INSERTED. THE CENTRAL VENOUS CATHETER KIT WAS THEN REPLACED, AFTER WHICH THE GUIDEWIRE WAS SUCCESSFULLY ADVANCED AND THE PROCEDURE COMPLETED. THE INCIDENT RESULTED IN ADDITIONAL PAIN DURING CATHETER PLACEMENT AND INCREASED THE POTENTIAL RISK OF BLEEDING. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: Pain
MAUDE report 25145964 ↗MalfunctionMay 6, 2026Fluid/Blood Leak
ON (B)(6) 2026, A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING THE HEMOSTAR HEMODIALYSIS CATHETER IN THE RIGHT INTERNAL JUGULAR VEIN. DURING THE PROCEDURE, THE INTRODUCER NEEDLE ALLEGEDLY LEAKED BLOOD. REPORTEDLY, THE CATHETER WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25090528 ↗MalfunctionApr 21, 2026Device Contaminated During Manufacture or Shipping
ON (B)(6) 2026, A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING THE HEMOSTAR HEMODIALYSIS CATHETER. DURING THE PROCEDURE, A HAIR WAS FOUND INSIDE THE CATHETER DURING THE OPERATION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24934592 ↗MalfunctionApr 6, 2026Failure to Advance; Deformation Due to Compressive Stress
ON (B)(6) 2026, THE PATIENT UNDERWENT A PLACEMENT PROCEDURE FOR INSERTION OF A LONG TERM HEMODIALYSIS CATHETER IN THE RIGHT INTERNAL JUGULAR VEIN USING THE HEMOSTAR. THE PATIENT HAD A CONFIRMED DIAGNOSIS OF STAGE 5 CHRONIC KIDNEY DISEASE AND WAS TAKEN TO THE OPERATING ROOM FOR THE PROCEDURE. THE CATHETER PLACEMENT WAS INITIATED UNDER GUIDEWIRE GUIDANCE. DURING INSERTION, THE CATHETER WAS ADVANCED INTO THE TEAR OFF SHEATH AND DILATOR ASSEMBLY. HOWEVER, IT WAS NOTED THAT THE CATHETER WAS NOT ADVANCING PROPERLY, AND THE TIP OF THE DILATOR WAS OBSERVED TO BE SLIGHTLY BENT AND DEFORMED. THE ANGLE WAS ADJUSTED, AND THE DILATOR WAS REINTRODUCED. UPON WITHDRAWAL OF THE GUIDEWIRE, THE GUIDEWIRE WAS ALSO FOUND TO BE BENT AND DEFORMED. DESPITE THESE ISSUES, THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE EVENT RESULTED IN INCREASED PAIN DURING CATHETER PLACEMENT AND AN INCREASED RISK OF BLEEDING. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: Pain
MAUDE report 24788071 ↗MalfunctionApr 6, 2026Restricted Flow rate; Suction Problem
ON (B)(6) 2025, THE PATIENT UNDERWENT RIGHT-SIDED SEMI-PERMANENT HEMODIALYSIS CATHETER PLACEMENT USING HEMOSTAR HEMODIALYSIS CATHETER TO REPLACE A DEFECTIVE CATHETER. POST THE PROCEDURE ON (B)(6) 2026, POOR BLOOD WITHDRAWAL WAS NOTED FROM THE RED END OF THE CATHETER, LEADING TO INADEQUATE HEMODIALYSIS. IT WAS FURTHER REPORTED THAT BLOOD FLOW WAS INADEQUATE. THERE WERE NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24787411 ↗MalfunctionApr 2, 2026Fluid/Blood Leak; Suction Problem
ON (B)(6) 2026, THE PATIENT UNDERWENT A SEMI PERMANENT DIALYSIS CATHETER PLACEMENT PROCEDURE IN THE RIGHT INTERNAL JUGULAR VEIN USING HEMOSTAR HEMODIALYSIS CATHETER. DURING THE PROCEDURE, IT WAS NOTED THAT BLOOD COULD NOT BE WITHDRAWN AND FURTHER REPORTED THAT BLOOD WAS LEAKED FORM THE TIP OF THE PUNCTURE NEEDLE. THE CATHETER WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24765977 ↗MalfunctionApr 2, 2026Device Contamination with Chemical or Other Material
ON (B)(6) 2026, A PATIENT WAS PREPPED FOR A DIALYSIS CATHETER PLACEMENT PROCEDURE USING THE HEMOSTAR DEVICE. PRIOR TO THE PROCEDURE, DURING PREPARATION AND WHILE THE PACKAGING REMAINED UNOPENED, AN UNKNOWN LIQUID WAS OBSERVED INSIDE THE CATHETER. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24762518 ↗MalfunctionMar 31, 2026Restricted Flow rate; Suction Problem
ON (B)(6) 2025, THE PATIENT UNDERWENT RIGHT SIDED SEMI PERMANENT HEMODIALYSIS CATHETER PLACEMENT USING HEMOSTAR HEMODIALYSIS CATHETER TO REPLACE DEFECTIVE CATHETER. ON (B)(6) 2026, SOMETIMES POST DIALYSIS CATHETER PLACEMENT PROCEDURE, POOR BLOOD WITHDRAWAL WAS NOTED FROM THE RED END OF THE CATHETER, LEADING TO INADEQUATE HEMODIALYSIS. IT WAS FURTHER REPORTED THAT BLOOD FLOW WAS INADEQUATE. THERE WAS NO PATIENT REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24740351 ↗MalfunctionMar 30, 2026Restricted Flow rate
ON (B)(6) 2026, A PATIENT WITH CHRONIC KIDNEY DISEASE STAGE 5 UNDERWENT A HEMODIALYSIS TREATMENT USING THE HEMOSTAR. DURING THE PROCEDURE INADEQUATE CATHETER BLOOD FLOW WAS OBSERVED. THE CATHETER WAS TREATED WITH UROKINASE. HOWEVER, THE VENOUS PRESSURE REMAINED HIGH. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24711853 ↗InjuryMar 25, 2026Difficult to Remove; Failure to Advance; Deformation Due to Compressive Stress
ON (b)(6) 2026, A PATIENT UNDERWENT A TRANSVENOUS LONG TERM DIALYSIS CATHETER IMPLANTATION PROCEDURE USING HEMOSTAR. DURING THE PROCEDURE, IT WAS NOTED THAT DUE TO KINKING OF THE TEAR OFF SHEATH, NORMAL INSERTION WAS NOT POSSIBLE. IT WAS ALSO REPORTED THAT THE SHEATH HAD TO BE REMOVED FORCIBLY BECAUSE THE PATIENT WAS BLEEDING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 24684756 ↗
Other Bard Access Systems, Inc. products
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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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