EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet 5913230Recalls & reported problems
Bard Access Systems, Inc. · EQUISTREAM XK HEMODIALYSIS CATH w/STYLET, ST, AIRGUARD, 16 FR. 23cm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Bard EQUISTREAM XK long-term hemodialysis catheter is an implanted tube used for dialysis access. The 31 reports mostly describe packaging and component problems — parts found broken or missing when the kit was opened, such as a cracked catheter hub, a broken dilator tip and a broken tunneler, plus one catheter that clogged months after placement and had to be removed. There were no deaths and one injury;30 reports were malfunctions. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 31
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00801741013843), received between Apr 17, 2018 and Mar 24, 2023 — classified as 1 injury, 30 malfunctions.
The most frequently reported specific device problem is “Defective Component” (14 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, 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
- Defective Component14
- Component Missing11
- Fracture2
- Component Incompatible1
- Contamination /Decontamination Problem1
- Detachment Of Device Component1
- Detachment of Device or Device Component1
- Material Frayed1
Patient problems
- No Patient Involvement16
- No Consequences Or Impact To Patient9
- No Clinical Signs, Symptoms or Conditions3
- Foreign Body In Patient1
- No Known Impact Or Consequence To Patient1
- Pain1
Recent adverse event reports
The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 24, 2023Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THROUGH RESULTS OF A CLINICAL TRIAL THAT ELEVEN MONTHS AND SEVENTEEN DAYS POST INDEX PROCEDURE COMPLETION, THE SUBJECT HAD ADVERSE EVENT OF CLOTTED CATHETER. IT WAS FURTHER REPORTED THAT, THE ADVERSE EVENT RELATIONSHIP TO STUDY DEVICE WAS POSSIBLY RELATED AND THUS THE ACTION WAS TAKEN TO REMOVE THE DEVICE. REPORTEDLY, THE CATHETER WAS REMOVED. THE PROCEDURE WAS COMPLETED EXCHANGING ANOTHER NEW CATHETER. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16608943 ↗MalfunctionJun 16, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT DURING DIALYSIS CATHETER PLACEMENT PROCEDURE IN THE RIGHT CHEST , A SMALL FRAGMENT WAS ALLEGEDLY FOUND IN ONE OF THE HUBS WHILE ASPIRATING. IT WAS FURTHER REPORTED THAT THE FRAGMENT DID NOT ENTER THE PATIENTS BODY. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12006433 ↗MalfunctionNov 10, 2020Fracture; Fracture
IT WAS REPORTED THAT DURING THE CATHETER PLACEMENT THROUGH RIGHT INTERNAL JUGULAR, THE CATHETER ALLEGEDLY CRACKED AT THE HUB. THE DEFECTIVE CATHETER WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10815287 ↗MalfunctionJun 6, 2019Defective Component; Defective Component
IT WAS REPORTED THAT THE TIP OF THE DILATOR ALLEGEDLY BROKE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8675553 ↗MalfunctionMay 29, 2019Defective Component; Defective Component
IT WAS REPORTED THAT THE TUNNELER WAS ALLEGEDLY BROKEN. THERE WAS NO PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 8650382 ↗MalfunctionApr 25, 2019Defective Component; Defective Component
IT WAS REPORTED THAT UPON OPENING THE PACKAGE THE BLUE PART OF THE TUNNELER WAS ALLEGEDLY BROKEN. REPORTEDLY, A NEW KIT WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 8550675 ↗MalfunctionApr 19, 2019Defective Component; Defective Component
IT WAS REPORTED THAT UPON REMOVAL FROM THE PACKAGING, THE WHITE PLASTIC TIP OF THE TUNNELER WAS ALLEGEDLY FOUND BROKEN. THERE WAS NO PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 8532028 ↗MalfunctionApr 19, 2019Defective Component; Defective Component
IT WAS REPORTED THAT UPON REMOVAL FROM THE PACKAGING, THE WHITE PLASTIC TIP OF THE TUNNELER WAS ALLEGEDLY FOUND BROKEN. THERE WAS NO PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 8531766 ↗MalfunctionApr 15, 2019Component Missing; Component Missing
IT WAS REPORTED THAT THE KIT ALLEGEDLY CONTAINED AN INCORRECT INTRODUCER SHEATH. REPORTEDLY, A NEW INTRODUCER SHEATH WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8515084 ↗MalfunctionApr 12, 2019Defective Component; Defective Component
IT WAS REPORTED THAT UPON OPENING THE PACKAGE THE TIP OF THE TUNNELER WAS ALLEGEDLY BROKEN. THERE WAS NO REPORTED PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 8509360 ↗MalfunctionApr 5, 2019Defective Component; Defective Component
IT WAS REPORTED THAT UPON OPENING THE PACKAGE, THE TUNNELER WAS ALLEGEDLY FOUND IN PIECES. THERE WAS NO PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 8489421 ↗MalfunctionMar 27, 2019Defective Component; Defective Component
IT WAS REPORTED THAT UPON OPENING THE PACKAGE, THE TUNNELER ALLEGEDLY WAS IDENTIFIED BROKEN. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 8458349 ↗MalfunctionMar 25, 2019Defective Component; Defective Component
IT WAS REPORTED THAT UPON OPENING THE RETURNED HEMODIALYSIS CATHETER KIT, THE TUNNELER TIP WAS FOUND ALLEGEDLY BROKEN. THERE WAS NO PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 8450069 ↗MalfunctionMar 25, 2019Defective Component; Defective Component
IT WAS REPORTED THE TIP OF THE TUNNELER ALLEGEDLY BROKE PRIOR TO PLACEMENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8449765 ↗MalfunctionMar 7, 2019Component Missing; Component Missing
IT WAS REPORTED THAT THE KIT ALLEGEDLY CONTAINED AN INCORRECT SHEATH. REPORTEDLY, A NEW KIT WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8401482 ↗MalfunctionMar 6, 2019Component Missing; Component Missing
IT WAS REPORTED THAT PRIOR TO USE ON PATIENT, THE INTRODUCER SHEATH WAS ALLEGEDLY IDENTIFIED TO BE 15F INSTEAD OF 16.5F THROUGH THE PACKAGING. IT WAS FURTHER REPORTED THAT THE DEVICE WAS NOT OPENED OR USED. THERE WAS NO PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 8396876 ↗MalfunctionMar 6, 2019Component Missing; Component Missing
IT WAS REPORTED THAT PRIOR TO USE ON PATIENT, THE INTRODUCER SHEATH WAS ALLEGEDLY IDENTIFIED TO BE 15F INSTEAD OF 16.5F THROUGH THE PACKAGING. IT WAS FURTHER REPORTED THAT THE DEVICE WAS NOT OPENED OR USED. THERE WAS NO REPORTED PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 8395887 ↗MalfunctionMar 6, 2019Component Missing; Component Missing
IT WAS REPORTED THAT PRIOR TO USE ON PATIENT, THE INTRODUCER SHEATH WAS ALLEGEDLY IDENTIFIED TO BE 15F INSTEAD OF 16.5F THROUGH THE PACKAGING. IT WAS FURTHER REPORTED THAT THE DEVICE WAS NOT OPENED OR USED. THERE WAS NO PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 8395675 ↗MalfunctionMar 6, 2019Component Missing; Component Missing
IT WAS REPORTED THAT PRIOR TO USE ON PATIENT, THE INTRODUCER SHEATH WAS ALLEGEDLY IDENTIFIED TO BE 15F INSTEAD OF 16.5F THROUGH THE PACKAGING. IT WAS FURTHER REPORTED THAT THE DEVICE WAS NOT OPENED OR USED. THERE WAS NO REPORTED PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 8395666 ↗MalfunctionMar 6, 2019Component Missing; Component Missing
IT WAS REPORTED THAT DURING PLACEMENT OF A LONG TERM HEMODIALYSIS CATHETER, THE INTRODUCER SHEATH WAS NOTED TO BE 15F INSTEAD OF 16.5F FOR THE 16F CATHETER AND WAS UNABLE TO BE USED TO PLACE THE CATHETER. IT WAS FURTHER REPORTED THAT ANOTHER SHEATH WAS USED TO COMPLETE PLACEMENT OF THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8395661 ↗MalfunctionMar 6, 2019Component Missing; Component Missing
IT WAS REPORTED THAT PRIOR TO USE ON PATIENT, THE INTRODUCER SHEATH WAS ALLEGEDLY IDENTIFIED TO BE 15F INSTEAD OF 16.5F THROUGH THE PACKAGING. IT WAS FURTHER REPORTED THAT THE DEVICE WAS NOT OPENED OR USED. THERE WAS NO REPORTED PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 8394831 ↗MalfunctionMar 6, 2019Component Missing; Component Missing
IT WAS REPORTED THAT DURING PLACEMENT OF A LONG TERM HEMODIALYSIS CATHETER, THE INTRODUCER SHEATH WAS NOTED TO BE 15F INSTEAD OF 16.5F FOR THE 16F CATHETER AND WAS UNABLE TO BE USED TO PLACE THE CATHETER. IT WAS FURTHER REPORTED THAT ANOTHER KIT WAS USED TO COMPLETE PLACEMENT OF THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8394830 ↗MalfunctionMar 5, 2019Defective Component; Defective Component
IT WAS REPORTED THAT THE TIP OF THE TUNNELER WAS ALLEGEDLY BROKEN OFF. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8392580 ↗MalfunctionMar 5, 2019Defective Component; Defective Component
IT WAS REPORTED THAT THE TIP OF THE TUNNELER WAS ALLEGEDLY BROKEN OFF. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8392577 ↗MalfunctionMar 1, 2019Defective Component; Defective Component
IT WAS REPORTED THAT UPON OPENING THE PACKAGE, THE TIP OF THE TUNNELER WAS IDENTIFIED BROKEN. IT WAS FURTHER REPORTED THAT ANTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 8383265 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page