Pristine 5403230Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741219047), received between Jan 13, 2022 and Sep 14, 2022 — classified as 3 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2022Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, AIR ALLEGEDLY LEAKED AROUND THE HUB ON THE ARTERIAL LUMEN SIDE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15415994 ↗
• InjuryAug 10, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED IN A CLINICAL STUDY THAT APPROXIMATELY, ONE MONTH AND TWENTY-FIVE DAYS POST AN ULTRASOUND GUIDED RIGHT INTERNAL JUGULAR VEIN APPROACH HEMODIALYSIS CATHETER PLACEMENT PROCEDURE, PATIENT HAD AN ADVERSE EVENT OF CLOTTED CATHETER. IT WAS FURTHER REPORTED THAT CATHETER WAS REMOVED AND EXCHANGED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15196954 ↗
• MalfunctionJul 20, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT SOMETIME POST DIALYSIS CATHETER PLACEMENT, DEVICE ALLEGEDLY HAD OBSTRUCTION OF FLOW. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15062799 ↗
• InjuryJul 12, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THROUGH A CLINICAL TRIAL, THAT APPROXIMATELY TWENTY DAYS POST DIALYSIS PLACEMENT PROCEDURE IN THE RIGHT INTERNAL JUGULAR VEIN APPROACH, PATIENT HAD AN ADVERSE EVENT OF CLOTTED CATHETER. IT WAS FURTHER REPORTED THAT CATHETER WAS REMOVED AND EXCHANGED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14984025 ↗
• MalfunctionJun 6, 2022Difficult to Insert; Difficult or Delayed Separation; Difficult to Insert; Difficult or Delayed Separation

  IT WAS REPORTED THAT SOMETIME POST PORT PLACEMENT, THE PEEL AWAY SHEATH FELL APART AND ALLEGEDLY START CRACKING ONE DILATOR WAS REMOVED. IT WAS FURTHER REPORTED THAT THE FINISHING INSERTION WAS ALLEGEDLY VERY DIFFICULT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14600567 ↗
• MalfunctionMar 19, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE PHYSICIAN ATTEMPTED TO PULL THE CATHETER MULTIPLE TIMES BUT KEPT DISCONNECTING MULTIPLE TIMES UNDER THE SKIN FROM TUNNELLER. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13826666 ↗
• MalfunctionMar 17, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A CATHETER PLACEMENT PROCEDURE, THE DEVICE TUNNELER ALLEGEDLY FELL OFF. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13791902 ↗
• InjuryMar 11, 2022Fracture; Difficult to Remove; Fracture; Difficult to Remove

  IT WAS REPORTED THAT POST DIALYSIS CATHETER PLACEMENT ON THE RIGHT JUGULAR, THE DEVICE WAS ALLEGEDLY CONTAMINATED WITH BACTERIA. UPON DEVICE REMOVAL, THE CUFF WAS NOTED TO BE STRONGLY ADHERING TO THE SKIN AND THE CATHETER WAS REPORTED TO BE BROKEN. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Bacterial Infection

  MAUDE report 13736567 ↗
• MalfunctionFeb 22, 2022Component Missing; Device Markings/Labelling Problem; Component Misassembled; Inaccurate Information; Component Missing; Device Markings/Labelling Problem; Component Misassembled; Inaccurate Information

  IT WAS REPORTED THAT PRIOR TO A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE LABELING OF THE CATHETER ALLEGEDLY FOUND TO BE MISLABELED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13576927 ↗
• MalfunctionFeb 22, 2022Component Missing; Device Markings/Labelling Problem; Component Misassembled; Inaccurate Information; Component Missing; Device Markings/Labelling Problem; Component Misassembled; Inaccurate Information

  IT WAS REPORTED THAT PRIOR TO A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE LABELING OF THE CATHETER ALLEGEDLY FOUND TO BE MISLABELED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13576919 ↗
• MalfunctionJan 13, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE TUNNELER ALLEGEDLY DETACHED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13251630 ↗