RetrO Long-Term Hemodialysis Catheter RS23SH28Recalls & reported problems
Bard Access Systems, Inc. · Pourchez RetrO HEMODIALYSIS CATH, 16 FR. 23cm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741014062), received between Oct 25, 2016 and May 15, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Aspiration Issue” (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
- Aspiration Issue1
- Crack1
- Fracture1
- Material Separation1
Patient problems
- No Known Impact Or Consequence To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 15, 2023Fracture; Material Separation; Fracture; Material Separation
IT WAS REPORTED THAT APPROXIMATELY SIX YEARS AND FOUR MONTHS POST DIALYSIS CATHETER PLACEMENT, THE CATHETER WAS ALLEGEDLY FOUND TO BE BROKEN. REPORTEDLY, THE CATHETER WAS REMOVED AND REPLACED WITH A NEW CATHETER. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16928698 ↗MalfunctionApr 18, 2017Aspiration Issue
IT WAS REPORTED THAT AFTER OPENING THE RETRO CATHETER, IT WAS PRIMED WITHOUT ANY PROBLEM OBSERVED. IT WAS STATED THAT THE CATHETER INSERTION WAS SMOOTH, BUT THE CATHETER COULD NOT BE ASPIRATED RIGHT AFTER THE PROCEDURE. THE RETRO CATHETER WAS THEN REMOVED AND A NEW RETRO CATHETER WAS USED FOR THE PATIENT WITHOUT ANY PROBLEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6501499 ↗MalfunctionOct 25, 2016Crack
FACILITY REPORTED THAT THEY FOUND CRACKING OF THE RED DEVICE OF A LINE ON THE RETRO PERCATH. INSERTION OF THE CATHETER WAS ON (B)(6) 2015 AND THE REPORTED CRACKING OF THE RED DEVICE OF THE LINE WAS FOUND ON (B)(6) 2016. NO PATIENT INJURY REPORTED. A REPAIR KIT WAS USED ON (B)(6) 2016.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6056107 ↗
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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