Gore TIPS Set TSET1016Recalls & reported problems
Creganna Unlimited Company · Gore TIPS Set · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 25391526210028), received between May 21, 2021 and Jul 28, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Most reported problems
Device problems
- Break2
- Crack2
Patient problems
- Device Embedded In Tissue or Plaque1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 28, 2021Break; Crack; Break; Crack
IT WAS REPORTED THE PHYSICIAN SELECTED A GORE TIPS SET FOR A FEMORAL VEIN RECANALIZATION PROCEDURE. IT WAS FURTHER REPORTED THAT THE SHEATH BROKE IN HALF. THEY WERE ABLE TO RETRIEVE ALL BUT A SMALL PIECE OF THE SHEATH WHICH REMAINS IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12240813 ↗InjuryMay 21, 2021Break; Crack; Break; Crack
IT WAS REPORTED THE PHYSICIAN SELECTED A GORE TIPS SET FOR A FEMORAL VEIN RECANALIZATION PROCEDURE. IT WAS FURTHER REPORTED THAT THE SHEATH BROKE IN HALF. THEY WERE ABLE TO RETRIEVE ALL BUT A SMALL PIECE OF THE SHEATH WHICH REMAINS IN THE PATIENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 11864012 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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