AV Sheath Tunneler AVST0200Recalls & reported problems

Bard Peripheral Vascular, Inc. · AV Sheath Tunneler Component, Handle · Class 2

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 00801741090523), received between May 5, 2025 and Aug 4, 2026 — classified as 2 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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Break1
Crack1
Failure to Disconnect1

Patient problems

No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

MalfunctionAug 4, 2026Break
On (b)(6) 2026, a patient underwent a surgical procedure using an AV Tunneler device. Reportedly, the rod broke off during use. There was no patient contact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50127306 ↗
MalfunctionMay 5, 2025Crack; Failure to Disconnect; Crack; Failure to Disconnect
ON (B)(6) 2025, A PATIENT UNDERWENT FOR AV SHEATH TUNNELER PROCEDURE. DURING THE PROCEDURE, THE MEDIUM CURVE ROD THAT CREWS INTO IT BECAME STUCK IN THE HANDLE AND A PORTION OF THE THREADED PART (OF VSTR 120) BROKE OFF INSIDE THE HANDLE UPON TRYING TO REMOVE IT AND THE ROD WAS NOT THREADED PROPERLY INTO THE HANDLE AND UNABLE TO GET IT OUT. THE DEVICE WAS ALLEGEDLY SNAPPED OFF INSIDE THE HANDLE. ANOTHER ROD AND HANDLE WERE USED TO COMPLETE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21958076 ↗

Device details

UDI-DI	`00801741090523`
Brand	AV Sheath Tunneler
Model	AVST0200
Company	Bard Peripheral Vascular, Inc.
Product code	MZY · Graft,vascular,stainless steel tunneler
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Mar 29, 2018

Device type (GMDN): Vascular graft tunneller

A long, surgical instrument used to tunnel an artificial passageway along vascular tissue planes to create a connecting channel typically for the introduction of a vascular graft or a vascular prosthesis. It can have a variety of designs, but basically it will be a long, round, stiff rod that tapers to a rounded point at the distal tip and have a handle at the proximal end to allow the surgeon to exert the necessary pressure and manipulation to push it through the body tissue. It will typically be made of high-grade stainless steel and possibly other materials for the handle, which may be detachable. This is a reusable device.

Other Graft,vascular,stainless steel tunneler devices

AV Sheath Tunneler AVST2000
Bard Peripheral Vascular, Inc. · Graft,vascular,stainless steel tunneler
4 reports
Peripheral Vascular Sheath Tunneler PVT1000
Bard Peripheral Vascular, Inc. · Graft,vascular,stainless steel tunneler
3 reports

All Graft,vascular,stainless steel tunneler 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page