Steady Sheath G25084Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002250840), received between Jun 12, 2017 and Feb 22, 2022 — classified as 3 injuries.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 22, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  AS REPORTED PER SALES REPRESENTATIVE ON 26JAN2022; THE METAL STABILIZING TIP BROKE OFF IN THE PATIENT IN THE UPPER LEFT CHEST. THEY WERE ABLE TO RETRIEVE IT WITH NO HARM TO THE PATIENT BUT THE SALES REPRESENTATIVE HAS NOT YET CONFIRMED THE METHOD USED TO RETRIEVE IT.

  Patient problems: Foreign Body In Patient

  MAUDE report 13581259 ↗
• InjuryJan 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE COURSE OF THE LEAD EXTRACTION PROCEDURE, A SMALL BLEED OCCURRED IN A MINOR BRANCH OF THE INNOMINATE VEIN. INTERVENTION WAS REQUIRED IN THE FORM OF A CHEST DRAIN AND BOTH LEADS WERE EXTRACTED SUCCESSFULLY. ACCORDING TO THE INITIAL REPORTER, AFTER PUTTING THE DRAIN IN AND CONTINUING WITH THE LEAD EXTRACTION, "PATIENT IS FINE." THE LEADS HAD BEEN IMPLANTED FOR OVER 17 YEARS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Perforation of Vessels

  MAUDE report 7178237 ↗
• InjuryJun 12, 2017Break; Device Operates Differently Than Expected; Break; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE PHYSICIAN WAS PERFORMING AN INTENDED PACEMAKER LEAD EXTRACTION PROCEDURE TO REMOVE AND REPLACE A PREVIOUSLY DAMAGED IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEAD MADE BY ANOTHER MANUFACTURER. THE PHYSICIAN USED A LEAD EXTRACTION STEADYSHEATH® EVOLUTION® TISSUE STABILIZATION SHEATH DURING THIS PROCEDURE. DUE TO HEAVILY CALCIFIED SCAR TISSUE, THE ICD LEAD BROKE. DURING THE ICD LEAD REMOVAL, THE METAL TIP OF THE LEAD EXTRACTION STEADYSHEATH® EVOLUTION® TISSUE STABILIZATION SHEATH BROKE OFF IN THE PATIENT¿S CLAVICLE. A NEW INTRODUCER WAS REQUIRED TO GAIN ACCESS TO THE PATIENT'S VASCULAR SYSTEM. IT WAS FURTHER REPORTED THAT THE PHYSICIAN WAS UNABLE TO RETRIEVE THE BROKEN PIECE OF THE METAL TIP; THEREFORE IT WAS LEFT INSIDE THE PATIENT¿S BODY. AN ADDITIONAL PROCEDURE WILL BE NECESSARY TO REMOVE THE TIP FROM THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED REGARDING THIS EVENT. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6633480 ↗