Hickman 0600654Recalls & reported problems

Bard Access Systems, Inc. · Hickman 12.5 Fr Triple-Lumen CV Catheter, with SureCuff Tissue Ingrowth Cuff, 51cm Tip-to-Cuff Length · Class 2 · Implant

All models of Hickman (28)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 3
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741051999), received between Sep 6, 2018 and Mar 27, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Component Misassembled” (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 16, 2026.

Most reported problems

Device problems

Component Misassembled1
Component Missing1
Difficult to Flush1
Fluid/Blood Leak1
Material Protrusion/Extrusion1
Obstruction of Flow1
Stretched1

Patient problems

No Clinical Signs, Symptoms or Conditions2
No Consequences Or Impact To Patient1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

MalfunctionMar 27, 2023Component Missing; Component Misassembled; Component Missing; Component Misassembled
IT WAS REPORTED THAT SOMETIMES POST CATHETER PLACEMENT PROCEDURE, CATHETER WAS ALLEGEDLY FOUND TO HAVE DOUBLE LUMEN INSTEAD OF TRIPLE LUMEN. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16619103 ↗
MalfunctionMar 27, 2023Difficult to Flush; Stretched; Obstruction of Flow; Material Protrusion/Extrusion; Difficult to Flush; Stretched; Obstruction of Flow; Material Protrusion/Extrusion
IT WAS REPORTED THAT SOMETIMES POST CATHETER PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY HAD A DIFFICULTY IN FLUSHING. IT WAS FURTHER REPORTED THAT THE DISTAL END OF THE LUMEN ALLEGEDLY BLOWS UP LIKE A BALLOON. REPORTEDLY, BOTH SIDES OF THE LUMEN ALLEGEDLY OCCLUDED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16618798 ↗
MalfunctionSep 6, 2018Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT WHEN FLUSHED WITH SALINE, THE BLUE LUMEN OF THE CATHETER LEAKED. THE CATHETER WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7851366 ↗

Device details

UDI-DI	`00801741051999`
Brand	Hickman
Model	0600654
Company	Bard Access Systems, Inc.
Product code	LJS · Catheter,intravascular,therapeutic,long-term greater than 30 days
Class	Class 2
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Aug 28, 2024

Device type (GMDN): Centrally-inserted central venous catheter

A flexible tube intended to be introduced into a neck or thoracic vein and often advanced into the superior vena cava for various infusion/aspiration procedures (i.e., non-dedicated) including the intravenous administration of nutrients, fluids, chemotherapeutic agents or other drugs, and blood sampling or delivery; it may also be used to monitor venous pressure. The proximal end of this central venous catheter (CVC) is typically fixed to the patient for long-term use. It may include supportive devices associated with introduction (e.g., guidewire, introducer); it is not primarily intended for extracorporeal blood therapies such as haemodialysis. This is a single-use device.

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

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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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