Steady Sheath G25083Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002250833), received between Sep 10, 2024 and Jun 9, 2025 — classified as 1 death, 1 injury.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathJun 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  WE REPORT A CASE IN WHICH SUPERIOR VENA CAVA (SVC) INJURY OCCURRED USING THE FOLLOWING PRODUCTS: EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET, STEADYSHEATH EVOLUTION® TISSUE STABILIZATION SHEATH, PHILIPPS/GLIDELIGHT 14FR, PHILIPPS/GLIDELIGHT 16FR, (IT IS UNCLEAR IN WHAT ORDER THE COOK PRODUCT EVOLUTION AND THE PHILIPS PRODUCT GLIDELIGHT WERE USED.). EACH ONE LEAD HAD BEEN PLACED IN THE RIGHT ATRIUM AND RIGHT VENTRICLE. AFTER REMOVAL OF THE ATRIAL LEAD, DURING DISSECTION OF THE AREA AROUND THE SVC FOR REMOVAL OF THE VENTRICULAR LEAD, THE PATIENT BLED AND BECAME HYPOTENSIVE; AN ATTEMPT WAS MADE TO STOP THE BLEEDING WITH A PHILIPPS/BRIDGE OCCULUSION BALLOON, FOLLOWED BY OPEN CHEST SURGERY, WHICH REVEALED AN INJURY OF THE SVC.

  Patient problems: Great Vessel Perforation; Low Blood Pressure/ Hypotension

  MAUDE report 22166008 ↗
• InjurySep 10, 2024Break; Adverse Event Without Identified Device or Use Problem; Separation Problem; Break; Adverse Event Without Identified Device or Use Problem; Separation Problem

  MEDICAL HISTORY: UNKNOWN. INFECTIOUS DISEASE: YES, BUT DETAILS UNKNOWN. APPROACH VIA LEFT SUBCLAVIAN VEIN, PLANNING TO USE IT FOR RV LEAD. WHEN LR-TSS-11.0 WAS SET ON EVOLUTION11FR AND USED IN FRONT OF SVC TO DETACH THE ADHESION OF RA LEAD, THE DETACHMENT DID NOT PROCEED. THEREFORE, THE PHYSICIAN ATTEMPTED TO REMOVE THE EVOLUTION11FR AND THE PRODUCT IN QUESTION, THE STAINLESS STEEL TIP OF THE PRODUCT CAME OFF. SINCE THERE WAS A POSSIBILITY THAT THE STAINLESS STEEL TIP MIGHT FLY TO OTHER PARTS OF THE BODY IF THE LR-TSS-11.0 WAS REMOVED AS IT WAS, A SHEATH FOR MEDTRONIC MICRA WAS INSERTED THROUGH THE FEMORAL VEIN AND THE TIP OF THE RA LEAD WAS RETRACTED. THE EVOLUTION 11FR AND LR-TSS-11.0 WERE ALSO INSERTED INTO THE MICRA SHEATH TO PREVENT THE STAINLESS STEEL TIP FROM FLYING OFF, AND A GUIDE WIRE WAS PASSED THROUGH THE EVOLUTION 11FR AND A VALVE WAS INSERTED THROUGH THE FEMORAL VEIN. THE BALLOON WAS PASSED THOUGH THE STAINLESS STEEL TIP AND INFLATED, THE STAINLESS STEEL TIP WAS FIXED WITH THE BALLOON, AND THEN REMOVED FROM THE FEMORAL VEIN. AFTER THE ADDITIONAL PROCEDURE, THE PATIENT WAS NO PROBLEMS. PHYSICIAN'S COMMENT OBTAINED BY A SALES REP FROM A DISTRIBUTOR : THE TIP WAS REMOVED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20184749 ↗