Groshong Catheter 9755305Recalls & reported problems

Bard Access Systems, Inc. · Groshong Catheter with Sherlock Tip Location System (TLS) Stylet 3F Basic Tray (Single-Lumen) (with Microintroducer) · Class 2 · Implant

All models of Groshong Catheter (7)

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

Adverse event reports: 4
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741036064), received between Sep 6, 2017 and Dec 7, 2018 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (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

Break1
Crack1
Fluid/Blood Leak1
Kinked1
Leak/Splash1
Material Frayed1

Patient problems

No Known Impact Or Consequence To Patient2
No Consequences Or Impact To Patient1
No Patient Involvement1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

MalfunctionDec 7, 2018Break; Crack
IT WAS REPORTED ON (B)(6) 2018, A NURSE AT THE FACILITY HAD A GUIDEWIRE BREAK AND REMAIN IN THE CATHETER DURING PLACEMENT. IT WAS RECOVERED AND NO PATIENT INJURY OCCURRED. APPROXIMATELY 1.5¿ OF THE GUIDEWIRE REMAINED IN THE CATHETER. THE NURSE STATED THAT THE "WIRE CRACKED/BROKE OFF WITHIN THE SHEATH¿(CATHETER).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8142032 ↗
MalfunctionSep 29, 2017Material Frayed; Kinked
FACILITY REPORTED TO THE SALES REP THAT AFTER THE PROCEDURE, THE WIRE CAME OUT KINKED, SHEARED AND APPEARED FRAYED. NURSE NOTED SOME OF THE COPPER COATING HAD BEEN STRIPPED OFF EXPOSING THE INNER LAYER BLUE WIRE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6905315 ↗
MalfunctionSep 14, 2017Leak/Splash
FACILITY REPORTED TO THE SALES REP THAT THE CATHETER LEAKED DURING PRE-FLUSH. LEAK WAS NOTED CLOSE TO THE DISTAL END OF THE CATHETER. DEVICE WAS NOT USED ON A PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6864955 ↗
MalfunctionSep 6, 2017Fluid/Blood Leak
FACILITY REPORTED TO THE SALES REP THAT THE CATHETER LEAKED PROXIMALLY DURING THE PRE-FLUSH. THE DEVICE WAS NOT USED ON THE PATIENT.
Patient problems: No Patient Involvement
MAUDE report 6847206 ↗

Device details

UDI-DI	`00801741036064`
Brand	Groshong Catheter
Model	9755305
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	Feb 19, 2021

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

A thin, flexible tube intended to be introduced into a peripheral vein and advanced to a central vein for short- to long-term intravascular access to administer medications (antibiotics), chemotherapeutic agents, nutrients, parenteral solutions, pain management fluids, and sometimes for blood sampling, monitoring of blood pressure and temperature, and for power injection of contrast media; it is not primarily intended for extracorporeal blood therapies such as haemodialysis. Also known as a peripherally inserted central catheter (PICC), it typically includes dedicated accessories to facilitate catheter introduction/function (e.g., Luer hubs, stylet). This is a single-use device.

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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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