Peripheral Vascular Sheath Tunneler PVT1000Recalls & reported problems

Bard Peripheral Vascular, Inc. · Peripheral Vascular Sheath Tunneler Set · Class 2

Data updated Oct 18, 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 00801741090257), received between Mar 1, 2021 and Jul 25, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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

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

Most reported problems

Device problems

Device Contamination with Chemical or Other Material2
Device Markings/Labelling Problem1
Material Erosion1

Patient problems

No Clinical Signs, Symptoms or Conditions3

Recent adverse event reports

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

MalfunctionJul 25, 2024Material Erosion; Device Contamination with Chemical or Other Material; Material Erosion; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT DURING A SURGICAL GRAFT PLACEMENT PROCEDURE, AFTER STERILIZATION, SOME MATERIALS WERE ALLEGEDLY FOUND TO BE DISSOLVED FROM THE SET. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19825523 ↗
MalfunctionNov 30, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT DURING A SURGICAL GRAFT IMPLANTATION PROCEDURE, THE SHEATH ALLEGEDLY ENDED UP LEAVING A BLACK RESIDUE ON THE GRAFT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18235462 ↗
MalfunctionMar 1, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT PV TUNNELER IFU ALLEGEDLY WAS NOT IN COMPLIANCE WITH GERMAN LAW. THE ACTUAL IFU WAS NOT MATCHING THE ACTUAL VALID ISO-NORMS REGARDING CLEANING AND STERILIZATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11395184 ↗

Device details

UDI-DI	`00801741090257`
Brand	Peripheral Vascular Sheath Tunneler
Model	PVT1000
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
AV Sheath Tunneler AVST0200
Bard Peripheral Vascular, Inc. · Graft,vascular,stainless steel tunneler
2 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.

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