EQUISTREAM Long-Term Hemodialysis Catheter 5905240Recalls & reported problems
Bard Access Systems, Inc. · EQUISTREAM HEMODIALYSIS CATH, ALPHACURVE, AIRGUARD, 14.5 FR. 24cm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741013805), received between Apr 4, 2018 and Mar 4, 2025 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Blocked Connection” (2 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
- Blocked Connection2
- Difficult to Advance2
- Difficult to Flush2
- Suction Problem2
- Break1
- Detachment of Device or Device Component1
- Expulsion1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Hemorrhage/Blood Loss/Bleeding1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 4, 2025Difficult to Flush; Suction Problem; Blocked Connection; Difficult to Advance; Difficult to Flush; Suction Problem; Blocked Connection; Difficult to Advance
IT WAS REPORTED THAT SOMETIMES POST A DIALYSIS CATHETER PLACEMENT PROCEDURE, THERE WAS DIFFICULT TO PLACE A LUMEN AND GET ACCESS FOR DIALYSIS. IT WAS FURTHER REPORTED THERE WAS DIFFICULT TO FLUSH AND GET BLOOD RETURN. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21514226 ↗MalfunctionMar 4, 2025Difficult to Flush; Suction Problem; Blocked Connection; Difficult to Advance; Difficult to Flush; Suction Problem; Blocked Connection; Difficult to Advance
IT WAS REPORTED THAT SOMETIMES POST A DIALYSIS CATHETER PLACEMENT PROCEDURE, THERE WAS DIFFICULT TO PLACE A LUMEN AND GET ACCESS FOR DIALYSIS. IT WAS FURTHER REPORTED THERE WAS DIFFICULT TO FLUSH AND GET BLOOD RETURN. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21514183 ↗InjuryOct 6, 2021Detachment of Device or Device Component; Expulsion; Detachment of Device or Device Component; Expulsion
IT WAS REPORTED THAT SOME TIME POST DIALYSIS CATHETER PLACEMENT, THE CATHETER ALLEGEDLY SHOT OUT OF THE TUNNEL TRACK DURING TREATMENT. IT WAS FURTHER REPORTED THAT PATIENT EXPERIENCED HEAVY BLEEDING. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 12583615 ↗MalfunctionApr 4, 2018Break
IT WAS REPORTED THAT DURING PLACEMENT OF THE DIALYSIS CATHETER THE TUNNELER BROKE, UNABLE TO PLACE THE DEVICE. NO OTHER INFORMATION WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7395998 ↗
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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