EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Stylet 5903270Recalls & reported problems
Bard Access Systems, Inc. · EQUISTREAM HEMODIALYSIS CATH w/STYLET, ST, AIRGUARD, 14.5 FR. 27cm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741013713), received between Mar 12, 2019 and Sep 27, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Defective Component” (3 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.
Reports received per month
Most reported problems
Device problems
- Defective Component3
- Difficult to Remove1
- Suction Problem1
Patient problems
- No Consequences Or Impact To Patient3
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 27, 2024Difficult to Remove; Suction Problem; Difficult to Remove; Suction Problem
IT WAS REPORTED THAT APPROXIMATELY FOUR WEEKS POST A DIALYSIS CATHETER PLACEMENT, THE CATHETER WAS ALLEGEDLY FAILED TO BE PULLED BACK. REPORTEDLY, THE CATHETER WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20318550 ↗MalfunctionMar 25, 2019Defective Component; Defective Component
IT WAS REPORTED THAT DURING DIALYSIS CATHETER PLACEMENT DURING INSERTION, THE TUNNELER COMPONENT ALLEGEDLY BROKE INSIDE CATHETER AND WAS REMOVED. IT WAS FURTHER REPORTED THAT ANOTHER CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8449769 ↗MalfunctionMar 25, 2019Defective Component; Defective Component
IT WAS REPORTED THAT DURING DIALYSIS CATHETER INSERTION, THE TUNNELER COMPONENT ALLEGEDLY BROKE INSIDE CATHETER AND WAS REMOVED. IT WAS FURTHER REPORTED THAT ANOTHER CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8449076 ↗MalfunctionMar 12, 2019Defective Component; Defective Component
IT WAS REPORTED THAT DURING DIALYSIS CATHETER INSERTION, THE TUNNELER COMPONENT ALLEGEDLY BROKE OFF IN THE CATHETER. IT WAS FURTHER REPORTED THAT ANOTHER KIT WAS USED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8414985 ↗
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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