RELIANCE XK Long-Term Hemodialysis Catheter 5327230Recalls & reported problems
Bard Access Systems, Inc. · RELIANCE XK HEMODIALYSIS CATH, ST, DL, 16 FR. 23cm · Class 2 · Implant
All models of RELIANCE XK Long-Term Hemodialysis Catheter (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741012105), received between Apr 18, 2017 and Aug 23, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Component Falling” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Component Falling1
- Detachment Of Device Component1
- Restricted Flow rate1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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 18, 2017Detachment Of Device Component; Component Falling
IT WAS REPORTED BY THE FACILITY VIA CUSTOMER SERVICE THAT THE CATHETER FELL OUT AFTER THE SUTURES WERE REMOVED, THE SUTURES ARE REMOVED AFTER A TWO WEEK PERIOD BASED ON THE CUSTOMER'S FACILITY POLICY. THIS FILE APPLIES TO LOT NUMBER REAW0802.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6501588 ↗
Other Catheter, hemodialysis, implanted devices
- Palindrome 8888145014Mozarc Medical US LLC · Catheter, hemodialysis, implanted1 recall312 reports
- Palindrome 8888145015Mozarc Medical US LLC · Catheter, hemodialysis, implanted2 recalls1 death219 reports
- HemoStar Long-Term Hemodialysis Catheter 5833690Bard Access Systems, Inc. · Catheter, hemodialysis, implanted2 deaths290 reports
- Palindrome 8888119369PMozarc Medical US LLC · Catheter, hemodialysis, implanted3 recalls1 death14 reports
- HemoStar Long-Term Hemodialysis Catheter 5833730Bard Access Systems, Inc. · Catheter, hemodialysis, implanted1 death141 reports
- GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet 5393230Bard Access Systems, Inc. · Catheter, hemodialysis, implanted5 deaths138 reports
- Palindrome 8888123404PMozarc Medical US LLC · Catheter, hemodialysis, implanted2 recalls1 death17 reports
- Palindrome 8888119364PMozarc Medical US LLC · Catheter, hemodialysis, implanted2 recalls1 death17 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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