Hickman Hemodialysis/Apheresis Catheter 0600692Recalls & reported problems
Bard Access Systems, Inc. · Hickman Hemodialysis/Apheresis Catheter 13.5F Dual-Lumen Catheter 40cm Overall Length, 23cm 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741037542), received between Jun 2, 2017 and Mar 2, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fitting Problem” (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
- Fitting Problem1
- Loose or Intermittent Connection1
- Material Frayed1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 2, 2023Loose or Intermittent Connection; Fitting Problem; Loose or Intermittent Connection; Fitting Problem
IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE PEEL AWAY SHEATH ALLEGEDLY FAILED TO LOCK AT THE HUB WHERE THE BLUE AREA CONNECTS. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16467214 ↗MalfunctionJun 2, 2017Material Frayed
FACILITY REPORTED THAT THE "GUIDEWIRE SHATTERED". NO OTHER INFORMATION WAS PROVIDED. NO REPORTED PATIENT HARM. ON 5/16/2017 - ADDITIONAL INFORMATION REPORTED BY THE FACILITY. THE INTRODUCER WAS INSERTED INTO THE PATIENT, WHEN DEVICE WAS BEING REMOVED THE HEALTHCARE PROFESSIONAL NOTED THAT THE WIRE HAD FRAYED INTO TWO SHREDS, ONE SHRED COMPLETELY CAME OFF. PATIENT WAS TAKEN TO FLUOROSCOPY AND HCP STATED NOTHING WAS LEFT IN THE PATIENT ARM. PATIENT WAS NOT INJURED. A NEW WIRE WAS USED TO COMPLETE THE PROCEDURE.
Patient problems: No Code Available
MAUDE report 6607698 ↗
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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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