Sentrant™ SENSH1828W (UDI 00643169150331)Recalls & reported problems
Medtronic, Inc. · SHEATH SENSH1828W SENTRANT HYDRO · Class 2
All models of Sentrant (21)
Data updated Oct 16, 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 00643169150331), received between Jan 25, 2018 and Jan 25, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Leak/Splash” (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 16, 2026.
Most reported problems
Device problems
- Leak/Splash1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 25, 2018Leak/Splash; Leak/Splash
A SENTRANT SHEATH WAS USED AS A CONDUIT IN THE ENDOVASCULAR TREATMENT OF A PATIENT. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE THERE WAS A LEAK FROM THE VALVE AROUND THE INSERTED GUIDEWIRE. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS DUE TO A DEFECTIVE VALVE. IT WAS NOTED THAT A SECOND 18FR SHEATH WAS OPENED AND USED SUCCESSFULLY TO RESOLVE THE EVENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7217932 ↗
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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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