Soft-Cell PC-2 Dialysis Catheter Kit 12.5 F x 19 cm 5534190Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00801741012440), received between Apr 27, 2017 and Mar 9, 2026 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2026Fracture

  A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING THE SOFTCELL CATHETER. POST PROCEDURE ON (B)(6) 2026, THE CATHETER CLAMP WAS FOUND TO BE BROKEN AND WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24542458 ↗
• InjuryMar 3, 2025Fluid/Blood Leak; Fracture; Deformation Due to Compressive Stress; Naturally Worn; Fluid/Blood Leak; Fracture; Deformation Due to Compressive Stress; Naturally Worn

  IT WAS REPORTED THAT TWO YEARS POST A DIALYSIS CATHETER PLACEMENT, THE PATIENT ALLEGEDLY EXPERIENCED BLOOD LEAKING OUT OF THE EXIT PORT. IT WAS FURTHER REPORTED THAT THE PATIENT WAS ALLEGEDLY HOSPITALIZED DUE TO SEPSIS. REPORTEDLY, THE CUFF WAS ALLEGEDLY FOUND TO BE DAMAGED, AND THE BLOOD WOULD COME OUT OF THE CUFF FOR BOTH THE ARTERY SIDE AND VEIN SIDE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Sepsis

  MAUDE report 21510863 ↗
• MalfunctionMay 21, 2024Fracture; Fracture

  IT WAS REPORTED THAT SOMETIME POST A DIALYSIS CATHETER PLACEMENT, THERE WAS ALLEGEDLY A CRACK IN THE BRANCH OF THE CATHETER. REPORTEDLY, THE CATHETER WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19357107 ↗
• MalfunctionFeb 2, 2021Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT SOMETIME POST DIALYSIS CATHETER PLACEMENT, THE DEVICE ALLEGEDLY HAD A BLOOD LEAK NEAR THE CONNECTOR. IT WAS FURTHER REPORTED THAT THE CATHETER ALLEGEDLY DAMAGED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11264660 ↗
• MalfunctionNov 11, 2020Suction Problem; Obstruction of Flow; Suction Problem; Obstruction of Flow

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE BLOOD WITHDRAWAL COULD NOT BE CONFIRMED AFTER INSERTING THE CATHETER. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10820998 ↗
• MalfunctionJun 8, 2020Loss of or Failure to Bond; Fluid/Blood Leak; Fracture; Loss of or Failure to Bond; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT APPROXIMATELY FOUR YEARS AND THREE MONTHS POST CATHETER PLACEMENT, THE CATHETER ALLEGEDLY FRACTURED IN TWO PIECES. IT WAS FURTHER REPORTED THAT THE CATHETER CUFF WAS ALLEGEDLY DETACHED. REPORTEDLY, THE CATHETER WAS REMOVED AND ANOTHER NEW CATHETER WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10127165 ↗
• MalfunctionApr 8, 2020Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT SOME TIME POST DIALYSIS CATHETER PLACEMENT, THE CATHETER ALLEGEDLY EXPERIENCED LEAKAGE. IT WAS FURTHER REPORTED THAT THE CATHETER WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9941566 ↗
• MalfunctionApr 2, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING DIALYSIS, A MATERIAL LIKE RUBBER PIECE WAS ALLEGEDLY ASPIRATED FROM THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9918094 ↗
• MalfunctionMar 17, 2020Obstruction of Flow; Material Deformation; Obstruction of Flow; Material Deformation

  IT WAS REPORTED THAT SOME TIME POST CATHETER PLACEMENT, THE CATHETER WAS ALLEGEDLY UNABLE TO BE ASPIRATED. REPORTEDLY, THE CATHETER WAS REMOVED AND DAMAGE WAS IDENTIFIED ON THE CATHETER NEAR THE CUFF. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9845196 ↗
• MalfunctionApr 8, 2019Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CATHETER WAS ALLEGEDLY LEAKING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8494042 ↗
• MalfunctionMar 25, 2019Component Incompatible; Material Frayed; Component Incompatible; Material Frayed

  IT WAS REPORTED THAT DURING PLACEMENT OF DIALYSIS CATHETER, THE GUIDEWIRE ALLEGEDLY WAS UNABLE TO ADVANCE THROUGH THE INTRODUCER NEEDLE. IT WAS FURTHER REPORTED THAT THE INTRODUCER NEEDLE AND THE GUIDEWIRE WERE REMOVED TOGETHER. REPORTEDLY, ANOTHER INTRODUCER NEEDLE AND GUIDEWIRE WAS USED TO PLACED THE INITIAL DIALYSIS CATHETER PROVIDED IN THE KIT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8450148 ↗
• MalfunctionFeb 14, 2019Component Incompatible; Material Frayed; Component Incompatible; Material Frayed

  IT WAS REPORTED THAT DURING THE PROCEDURE THE GUIDEWIRE BECAME ALLEGEDLY STUCK, THEREFORE, THE HEALTH CARE PROVIDER ATTEMPTED TO MANIPULATE THE GUIDEWIRE UNSUCCESSFULLY. REPORTEDLY, THE DEVICE WAS REMOVED. ANOTHER KIT WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8341781 ↗
• MalfunctionDec 10, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT APPROXIMATELY ELEVEN MONTHS AFTER THE SOFT CELL DIALYSIS CATHETER WAS PLACED DURING ADMINISTRATION OF HEPARIN SALINE, THE CATHETER WAS IDENTIFIED TO BE ALLEGEDLY DEFORMED AND DISCOLORED. IT WAS FURTHER REPORTED A FEW WEEKS AFTER THE REPORTED ISSUE OCCURRED THE DEVICE WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8149092 ↗
• MalfunctionMar 6, 2018Air Leak

  IT WAS REPORTED THAT THE CATHETER WAS IMPLANTED VIA THE RIGHT INTERNAL JUGULAR VEIN IN (B)(6) 2014. AIR INFILTRATION WAS ALSO REPORTED WHEN BLOOD WAS BEING DRAWN. POOR BLOOD REMOVAL IN THE CATHETER WAS OBSERVED, SO UROKINASE AND ETC. WERE APPLIED TO IMPROVE THE BLOOD FLOW IN (B)(6) 2018. HEPARIN ASPIRATION AND SALINE FLUSH PRIOR USAGE OF THE CATHETER WERE PERFORMED WITH NO PROBLEM ON (B)(6) 2018. HEPARIN ASPIRATION AND SALINE FLUSH PRIOR USAGE OF THE CATHETER WERE PERFORMED SUCCESSFULLY AND THE CATHETER WAS CONNECTED TO THE DIALYSIS CIRCUIT. HOWEVER, APPROXIMATELY FIVE MINUTES POST STARTING DIALYSIS, AIR FILTRATION WAS ALLEGEDLY OBSERVED FROM THE CATHETER INTO THE EXTENSION TUBE CONNECTED BETWEEN IT AND THE DIALYSIS CIRCUIT ON (B)(6) 2017. THE CATHETER WAS EXCHANGED ON (B)(6) 2018. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7318008 ↗
• MalfunctionDec 15, 2017Occlusion Within Device; Aspiration Issue

  IT WAS REPORTED THAT AFTER COMPLETING THE PLACEMENT PROCEDURE OF THE DEVICE, THE HEALTHCARE PROFESSIONAL (HCP) FAILED TO ASPIRATE BLOOD. THEREFORE, THE HCP SUSPECTED OCCLUSION OF THE DEVICE AND REMOVED IT FROM THE PATIENT. A NEW DEVICE WAS PLACED, THAT WAS USED BY ANOTHER MANUFACTURER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7121363 ↗
• MalfunctionAug 1, 2017Leak/Splash

  IT WAS REPORTED THAT LEAKAGE OF BLOOD FROM THE JUNCTION OF THE EXTENSION TUBE WAS FOUND DURING ARTIFICIAL DIALYSIS. AS THE DOCTOR SUSPECTED THAT THE CATHETER MAY HAVE BEEN DAMAGED, THE CATHETER WAS REMOVED FROM THE PATIENT IN JULY. ARTIFICIAL DIALYSIS IS CURRENTLY PERFORMED WITH A SHUNT WHICH WAS INSERTED PREVIOUSLY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 6758896 ↗
• MalfunctionApr 27, 2017Crack

  IT WAS REPORTED THAT, BECAUSE AIR WAS DRAWN FROM THE LINE, THE LINE WAS INSPECTED AND A SPLIT WAS FOUND IN THE HUB. THE CATHETER HAD BEEN IMPLANTED ABOUT TWO YEARS AND A HALF EARLIER. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6527419 ↗