Sentrant™ SENSH1828W (UDI 00763000716264)Recalls & reported problems
Medtronic, Inc. · SENTRANT INTRODUCER SHEATH 18 FR X 28 CM · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000716264), received between Apr 12, 2024 and Apr 12, 2024 — classified as 1 injury.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Vascular Dissection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A SENTRANT SHEATH ((B)(6)) WAS USED AS A CONDUIT DURING THE IMPLANT OF A TRANSCATHETER BIOPROSTHETIC VALVE. AT IMPLANT THE DIAMETER OF THE RIGHT FEMORAL ACCESS VESSEL WAS 5.92MM TORTUOUS CALCIFIED ANATOMY WAS NOTED. IT WAS REPORTED DURING THE INDEX PROCEDURE, THE 18FR SENTRANT SHEATH ADVANCED WITH EASE. A SERIES OF WIRE AND CATHETER EXCHANGES OCCURRED AND A PRE-DILATION WAS COMPLETED WITH A NON MDT BALLOON. WHEN THE 18FR SENTRANT WAS WITHDRAWN, THE VALVE DELIVERY SYSTEM (DCS) WAS ADVANCED BUT COULD NOT BE ADVANCED BEYOND THE EXTERNAL ILIAC. THE PHYSICIAN ATTEMPTED TO ADVANCE THE 18FR SENTRANT BUT WAS UNABLE TO ADVANCE BEYOND THE EXTERNAL ILIAC. AN ANGIOSCAN REVEALED A DISSECTION IN THE RIGHT EXTERNAL ILIAC. A BALLOON WAS PLACED FOR HEMOSTASIS AND A NON MDT STENT PLACED. THE TAVR PORTION OF THE PROCEDURE WAS ENDED. PER THE PHYSICIAN THE DISSECTION WAS CAUSED BY PATIENT ANATOMY DUE TO THE PATIENT'S TORTUOUS AND CALCIFIED ANATOMY AND THE INTRODUCTION OF THE EXTERNAL SHEATH WHICH PREVENTED THE DELIVERY SYSTEM FROM BEING ADVANCED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.
Patient problems: Vascular Dissection
MAUDE report 19095288 ↗
Other Introducer, catheter devices
- VIZIGO D138502Biosense Webster Inc · INTRODUCER, CATHETER2 recalls4 deaths2,839 reports
- VIZIGO D138501Biosense Webster Inc · INTRODUCER, CATHETER2 recalls2 deaths2,005 reports
- Swartz™ 407451St. Jude Medical, Inc. · INTRODUCER, CATHETER5 deaths728 reports
- Edwards eSheath+ Introducer set 914ESPEdwards Lifesciences LLC · Introducer, Catheter22 deaths532 reports
- Fast-Cath™ 406849St. Jude Medical, Inc. · INTRODUCER, CATHETER420 reports
- VIZIGO D138503Biosense Webster Inc · INTRODUCER, CATHETER362 reports
- Agilis™ G408318St. Jude Medical, Inc. · INTRODUCER, CATHETER333 reports
- Agilis™ NxT Steerable Introducer Dual-Reach™ SI-1371-MSt. Jude Medical, Inc. · Introducer, catheter1 death301 reports
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 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