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Hickman Hemodialysis/Apheresis Catheter 0600450Recalls & reported problems

Bard Access Systems, Inc. · Hickman Hemodialysis/Apheresis Catheter 13.5F Dual-Lumen Catheter, 45cm Overall Length, 28 cm Tip-to-Cuff Length, Standard Kit (with Peel-Apart Introducer) · Class 2 · Implant

All models of Hickman Hemodialysis/Apheresis Catheter (7)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
5
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741037443), received between Aug 10, 2017 and Oct 16, 2019 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Device Dislodged or Dislocated3
  • Defective Component1
  • Device Operates Differently Than Expected1
  • Expulsion1
  • Hole In Material1
  • Loosening of Implant Not Related to Bone-Ingrowth1

Patient problems

  • No Consequences Or Impact To Patient3
  • Extravasation1
  • No Clinical Signs, Symptoms or Conditions1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 16, 2019Defective Component; Device Dislodged or Dislocated; Expulsion; Loosening of Implant Not Related to Bone-Ingrowth; Defective Component; Device Dislodged or Dislocated; Expulsion; Loosening of Implant Not Related to Bone-Ingrowth

    THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 0600450 DIALYSIS CATHETER ALLEGEDLY FAILED TO ADHERE TO THE TISSUE AND RESULTED IN CATHETER DISLODGMENT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED AND THERE WAS NO REPORTED PATIENT INJURY. PATIENT INFORMATION WAS NOT PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

    MAUDE report 9200130 ↗
  • MalfunctionSep 27, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

    IT WAS REPORTED THAT THE CATHETER DISLODGED AND FELL OUT OF THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7914464 ↗
  • MalfunctionSep 26, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

    IT WAS REPORTED THAT THE CATHETER DISLODGED AND FELL OUT OF THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7912798 ↗
  • MalfunctionJan 29, 2018Hole In Material

    IT WAS REPORTED BY THE FACILITY THAT THEY HAD A HICKMAN CATHETER THAT HAD MULTIPLE HOLES IN IT. THEY STATED THE CATHETER HAD TWO HOLES IN THE BLUE LUMEN AND ONE IN THE RED LUMEN PRIOR TO THE Y-SITE. NO PATIENT INJURY REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7224849 ↗
  • MalfunctionAug 10, 2017Device Operates Differently Than Expected

    REPORTED EXTRAVASATION OF SERUM THERAPY, VIA INSERTION OF CATHETER. AFTER BONE MARROW TRANSPLANT, PATIENT RECEIVED CONTINUOUS SERUM THERAPY. HEALTHCARE PROFESSIONAL ALLEGES CLEFT IN CATHETER. NO PATIENT INJURY WAS REPORTED.

    Patient problems: Extravasation

    MAUDE report 6786180 ↗

Other Catheter,intravascular,therapeutic,long-term greater than 30 days devices

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Sources and updates

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