Hickman Hemodialysis/Apheresis Catheter 0600662Recalls & reported problems
Bard Access Systems, Inc. · Hickman Hemodialysis/Apheresis 13.5 Fr. Dual Lumen Catheter 36cm Overall Length, 19cm Tip-to-Cuff Length Standard Kit (13.5F) (Open-Ended Catheter) (Dual-Lumen) · 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
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741037511), received between Sep 6, 2016 and Jan 9, 2024 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (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.
Reports received per month
Most reported problems
Device problems
- Fracture2
- Break1
- Deformation Due to Compressive Stress1
- Detachment Of Device Component1
- Difficult to Insert1
- Entrapment of Device1
- Material Separation1
Patient problems
- No Known Impact Or Consequence To Patient2
- Air Embolism1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJan 9, 2024Entrapment of Device; Fracture; Difficult to Insert; Material Separation; Deformation Due to Compressive Stress; Entrapment of Device; Fracture; Difficult to Insert; Material Separation; Deformation Due to Compressive Stress
IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE DEVICE LINE WAS ALLEGEDLY CAUGHT ON THE TISSUE. IT WAS FURTHER REPORTED THAT THE LINE ALLEGEDLY KINKED AND WHEN ATTEMPTED TO STRAIGHTEN THE LINE, THE LINE ALLEGEDLY GOT SNAPPED. FURTHERMORE, THE LINE WAS ALLEGEDLY FRACTURED, AND SNARE AND FORCEPS WERE USED TO RETRIEVE THE BROKEN LINE PIECES. REPORTEDLY, THE PATIENT ALLEGEDLY EXPERIENCED AIR EMBOLISM WHICH REQUIRED OXYGEN AND PATIENT REPOSITION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Air Embolism
MAUDE report 18473059 ↗MalfunctionJan 29, 2021Fracture; Fracture
IT WAS REPORTED THAT PRIOR TO A PROCEDURE, THE DEVICE PLASTIC PIECE SNAPPED APART. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11249130 ↗MalfunctionJun 15, 2017Break
IT WAS REPORTED BY THE FACILITY THAT THE PATIENT HAD CATHETER PLACED FOR A DURATION OF 3 DAYS FOR TREATMENT. AFTER COMPLETING TREATMENT, IT WAS NOTED THAT THE CATHETER WAS BROKEN AT THE CUFF. PATIENT HAD SURGERY TO REMOVE THE BROKEN PIECE. NO HARM TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6644545 ↗MalfunctionSep 6, 2016Detachment Of Device Component
ON (B)(6) 2016 - FACILITY REPORTED DURING INSERTION OF THE DEVICE, ALLEGEDLY THE WIRE CAME APART. THE PROCEDURE WAS STOPPED, A NEW DEVICE WAS OPENED TO COMPLETE THE PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5931269 ↗
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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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