Peripheral Vascular Sheath Tunneler PVT0100Recalls & reported problems
Bard Peripheral Vascular, Inc. · Peripheral Vascular Sheath Tunneler Sterilization Cassette · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741090264), received between Jun 4, 2026 and Jun 4, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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
Most reported problems
Device problems
- Device-Device Incompatibility1
- Positioning Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 4, 2026Device-Device Incompatibility; Positioning Problem
A PATIENT UNDERWENT A SURGICAL GRAFT PLACEMENT PROCEDURE USING A PV TUNNELER. IT WAS REPORTED THAT THE HANDLE OF THE TUNNELER WAS LOOSE, AND THE DEVICE WAS UNABLE TO ROTATE DURING THE CREATION OF THE PASSAGE IN THE VESSEL. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25387027 ↗
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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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