RELIANCE XK Long-Term Hemodialysis CatheterRecalls & reported problems across all models
Bard Access Systems, Inc. · 6 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 23
- Deaths reported
- 1
- Injuries reported
- 2
- Recalls
- 0
We found 6 models of RELIANCE XK Long-Term Hemodialysis Catheter by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 23 adverse event reports in the FDA's MAUDE database, received between Feb 17, 2017 and Feb 19, 2025 — classified as 1 death, 2 injuries, 20 malfunctions.
The most frequently reported specific device problem is “Break” (6 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 RELIANCE XK Long-Term Hemodialysis Catheter problems
Device problems
- Break6
- Material Twisted/Bent4
- Kinked3
- Component Falling2
- Component Missing2
- Detachment Of Device Component2
- Fluid/Blood Leak2
- Fracture2
Patient problems
- No Known Impact Or Consequence To Patient11
- No Clinical Signs, Symptoms or Conditions4
- No Consequences Or Impact To Patient2
- No Patient Involvement2
- Air Embolism1
- Foreign Body In Patient1
- Insufficient Information1
- Unspecified Infection1
RELIANCE XK Long-Term Hemodialysis Catheter models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- RELIANCE XK Long-Term Hemodialysis Catheter 5327190Catheter, hemodialysis, implanted7 reports
- RELIANCE XK Long-Term Hemodialysis Catheter 5323230Catheter, hemodialysis, implanted1 death6 reports
- RELIANCE XK Long-Term Hemodialysis Catheter 5323190Catheter, hemodialysis, implanted5 reports
- RELIANCE XK Long-Term Hemodialysis Catheter 5323420Catheter, hemodialysis, implanted2 reports
- RELIANCE XK Long-Term Hemodialysis Catheter 5327230Catheter, hemodialysis, implanted2 reports
- RELIANCE XK Long-Term Hemodialysis Catheter 5323310Catheter, hemodialysis, implanted1 report
Recent RELIANCE XK 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.
MalfunctionFeb 19, 2025Difficult to Flush; Suction Problem; Failure to Advance; Deformation Due to Compressive Stress; Difficult to Flush; Suction Problem; Failure to Advance; Deformation Due to Compressive Stress
IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE WIRE WAS DIFFICULT TO THREAD THROUGH THE ARTERIAL PORT OF THE CATHETER. IT WAS FURTHER REPORTED THAT TRIED TO ASPIRATE THROUGH THE PORT, THERE WAS RESISTANCE FELT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21408563 ↗MalfunctionAug 24, 2022Restricted Flow rate; Restricted Flow rate
IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE VIA INTERNAL JUGULAR VEIN, THE DEVICE ALLEGEDLY HAD A LOW FLOW RATE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15283563 ↗MalfunctionAug 23, 2022Restricted Flow rate; Restricted Flow rate
IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY HAD A LOW FLOW RATE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15273926 ↗MalfunctionApr 27, 2022Fracture; Material Separation; Fracture; Material Separation
IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE TUNNELER ALLEGEDLY FOUND TO BE BROKEN. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14219191 ↗InjuryJul 15, 2021Fluid/Blood Leak; Fracture; Air/Gas in Device; Fluid/Blood Leak; Fracture; Air/Gas in Device
IT WAS REPORTED THAT SOME TIME POST CATHETER PLACEMENT, THE AIR GUARD WAS ALLEGEDLY LEAKED AND BOLUS OF AIR ENTERED INTO THE PATIENT. THE PATIENT CURRENT STATUS IS UNKNOWN.
Patient problems: Air Embolism
MAUDE report 12171496 ↗DeathOct 7, 2020Malposition of Device; Malposition of Device
IT WAS REPORTED THAT DURING DIALYSIS CATHETER PLACEMENT IN THE RIGHT INTERNAL JUGULAR ACCESS, THE INTRODUCER CATHETER ALLEGEDLY MALPOSITIONED. IT WAS FURTHER REPORTED THAT THE CATHETER WAS REMOVED, ALLEGEDLY CAUSING THE PATIENT TO BECOME HEMODYNAMICALLY COMPROMISED. REPORTEDLY, THE PATIENT WAS RESUSCITATED, AND A STERNOTOMY REVEALED A SUPERIOR VENA CAVA INJURY. THE PATIENT REPORTEDLY EXPIRED.
Patient problems: Insufficient Information
MAUDE report 10646110 ↗MalfunctionNov 19, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT SOME TIME POST DIALYSIS CATHETER PLACEMENT, AN ALLEGED LEAK WAS IDENTIFIED ABOVE BIFURCATION; DISTAL TO THE CONNECTION. REPORTEDLY, THE DEVICE WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9341827 ↗MalfunctionAug 10, 2018Component Missing; Component Missing
IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE KIT WAS ALLEGEDLY MISSING THE TUNNELER. IT WAS FURTHER REPORTED ANOTHER KIT WAS OPENED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Patient Involvement
MAUDE report 7772397 ↗MalfunctionAug 9, 2018Component Missing; Component Missing
IT WAS REPORTED THAT THE DEVICE KIT WAS ALLEGEDLY MISSING THE TUNNELER. THERE WAS NO PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 7770853 ↗MalfunctionFeb 6, 2018Material Twisted/Bent
IT WAS REPORTED BY THE SALES REP THAT THE CATHETER WAS PLACED ON (B)(6) 2017, AND "ISSUES" WERE FIRST REPORTED BY THE DIALYSIS UNIT AND THE CATHETER WAS REMOVED LAST WEEK. HE STATED THE CATHETER WOULD RUN FINE, BUT OCCASIONALLY THE EXTENSION TUBING WOULD TWIST, WHICH IS WHAT EVENTUALLY CAUSED THE CATHETER TO BE EXCHANGED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7246265 ↗InjuryJan 11, 2018Insufficient Device Problem Information
IT WAS REPORTED THAT THE CATHETER WAS REMOVED AT AN OUTPATIENT DIALYSIS SETTING DUE TO AN INFECTION. THE FACILITY DOES NOT BELIEVE THE INFECTION HAD TO DO WITH THE CATHETER.
Patient problems: Unspecified Infection
MAUDE report 7183095 ↗MalfunctionJan 4, 2018Kinked; Material Integrity Problem; Material Twisted/Bent
A (RN) REGISTERED NURSE AT THE FACILITY REPORTED TO THE SALES REP THAT THE PLASTIC EXTENSION TUBING OF THE RELIANCE XK CATHETER TWISTED AND KINKED. IT WAS STATED THAT AN UNUSUALLY HIGH RATE WAS NOTED WHEN DIALYZING THROUGH THE CATHETER. THE RN EXPRESSED IT SEEMS AS THOUGH THE TUBING IS MUCH THINNER THAN WHAT THE STAFF HAS PREVIOUSLY NOTICED WITH THE SAME CATHETERS. THERE HAVE NOT BEEN ANY CHANGES WITH THE CATHETER MAINTENANCE, CLEANSING OR CATHETER LOCKING PROCEDURES. NO PATIENT INJURY REPORTED. THIS FILE ADDRESSES PATIENT TWO OF LOT REBS1588.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7164103 ↗MalfunctionJan 4, 2018Kinked; Material Twisted/Bent
A RN AT THE FACILITY REPORTED TO THE SALES REP THAT THE PLASTIC EXTENSION TUBING OF THE RELIANCE XK CATHETER TWISTED AND KINKED. IT WAS STATED THAT AN UNUSUALLY HIGH RATE WAS NOTED WHEN DIALYZING THROUGH THE CATHETER. THE RN EXPRESSED IT SEEMS AS THOUGH THE TUBING IS MUCH THINNER THAN WHAT THE STAFF HAS PREVIOUSLY NOTICED WITH THE SAME CATHETERS. THERE HAS NOT BEEN ANY CHANGES TO THE CATHETER MAINTENANCE, CLEANSING OR CATHETER LOCKING PROCEDURES. NO PATIENT INJURY REPORTED. THIS FILE ADDRESSES PATIENT ONE OF LOT REBS1588.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7164100 ↗MalfunctionJan 4, 2018Kinked; Material Integrity Problem; Material Twisted/Bent
A REGISTER NURSE AT THE FACILITY REPORTED TO THE SALES REP THAT THE PLASTIC EXTENSION TUBING OF THE RELIANCE XK CATHETER TWISTED AND KINKED. IT WAS STATED THAT AN UNUSUALLY HIGH RATE WAS NOTED WHEN DIALYZING THROUGH THE CATHETER. THE REGISTER NURSE EXPRESSED IT SEEMS AS THOUGH THE TUBING IS MUCH THINNER THAN WHAT THE STAFF HAS PREVIOUSLY NOTICED WITH THE SAME CATHETERS. THERE HAVE NOT BEEN AN CHANGES TO THE CATHETER MAINTENANCE, CLEANSING OR CATHETER LOCKING PROCEDURES. NO PATIENT INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7164014 ↗MalfunctionMay 18, 2017Break
IT WAS REPORTED BY THE FACILITY VIA THE SALES REP THAT THE CLAMP BROKE WHEN THE PATIENT CAME IN FOR DIALYSIS, IT WAS THE ARTERIAL CLAMP. ON 5/11/17-THE FACILITY CONTACT STATED THAT THEY USE PEROXIDE TO CLEAN THE DEVICE PRIOR TO DRESSING CHANGE. THE FACILITY CONTACT STATED THE CLAMPS WERE NOT BRITTLE. THE CLAMPS BROKE ON THE BACK IN A "STRAIGHT CLEAN" LINE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6575202 ↗
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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