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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 1 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

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 ↗

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

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Sources and updates

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