Steady Sheath G25082Recalls & reported problems
Cook Vandergrift Inc. · SteadySheath 9 Fr Evolution Tissue Stabilization Sheath · Class 2
Data updated Oct 16, 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 00827002250826), received between Jun 4, 2025 and Jun 4, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Detachment of Device or Device Component1
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.
InjuryJun 4, 2025Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem
A PACEMAKER LEAD WAS PLACED IN THE RIGHT ATRIUM AND THE RIGHT VENTRICLE (RV), RESPECTIVELY, FROM THE LEFT CHEST AND A POCKET INFECTION WAS NOTED AFTER 7 YEARS. FIRSTLY, THE RV LEAD WAS ATTEMPTED TO BE REMOVED. AN EVOLUTION® SHORTIE RL CONTROLLED-ROTATION DILATOR SHEATH SET (EVN-SH) WAS USED TO ABOUT THE ANONYMOUS VEIN AND THEN A GLIDELIGHT12 WAS USED. HOWEVER, THE GLIDELIGHT12 WAS UNABLE TO ADVANCE AT ALL ABOUT FROM THE RIGHT ATRIUM (RA) SUPERIOR VENA CAVA (SVC) JUNCTION. THE USER DETERMINED THE ADHESION STRONG AND USED EVOLUTION® RL CONTROLLED-ROTATION DILATOR SHEATH SET (EVN) AT THE BEGINNING, BUT THE PEELING OF THE SHEATH WAS NOT SUFFICIENT, THEREFORE, THE USER COVERED THE EVN WITH A STEADYSHEATH® EVOLUTION® TISSUE STABILIZATION SHEATH (TSS) AND REMOVED THE RV LEAD USING THE EVN. SECONDLY, THE USER ATTEMPTED TO APPROACH THE RA LEAD. THE USER PEELED TO ABOUT THE ANONYMOUS VEIN WITH THE EVN-SH, AND THEN THE USER COVERED THE EVN WITH THE TSS LIKE THE RV LEAD REMOVAL AND ATTEMPTED PEELING. HOWEVER, THE SHEATH HAD DIFFICULTY IN ADVANCING AT RA SVC JUNCTION. THEREFORE, THE USER ONCE ATTEMPTED TO REMOVE THE EVN AND THE TSS FROM THE ANATOMY, AND DURING THIS ATTEMPT, THE METAL PART OF TH
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22140170 ↗
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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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