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Pristine 5403280Recalls & reported problems

Bard Peripheral Vascular, Inc. · Pristine Long-Term Hemodialysis Catheter, 28 cm · Class 2 · Implant

All models of Pristine (3)

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 00801741219054), received between Jan 3, 2022 and Sep 4, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

Most reported problems

Device problems

  • Detachment of Device or Device Component2
  • Contamination /Decontamination Problem1
  • Dent in Material1
  • Free or Unrestricted Flow1
  • Loss of or Failure to Bond1

Patient problems

  • No Clinical Signs, Symptoms or Conditions4

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 4, 2023Loss of or Failure to Bond; Dent in Material; Free or Unrestricted Flow; Loss of or Failure to Bond; Dent in Material; Free or Unrestricted Flow

    IT WAS REPORTED THAT SOMETIME POST A DIALYSIS CATHETER PLACEMENT, THE CATHETER ALLEGEDLY HAD INDENTATION IN VENOUS/BLUE LUMEN UNDER FIBRO GENIC CUFF. IT WAS FURTHER REPORTED THAT THE CATHETER ALLEGEDLY HAD HIGH PRESSURES PROBLEMS, DIFFICULTY WITH ASPIRATION AND FLOW ISSUES. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17675389 ↗
  • MalfunctionDec 2, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

    IT WAS REPORTED THAT PRIOR TO DIALYSIS CATHETER PLACEMENT PROCEDURE, FOREIGN MATERIAL WAS ALLEGEDLY FOUND ON THE PACKAGE. THERE WAS NO PATIENT CONTACT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15903191 ↗
  • MalfunctionJun 2, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

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

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14571521 ↗
  • MalfunctionJan 3, 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. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13141104 ↗

Other Catheter, hemodialysis, implanted devices

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Sources and updates

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