Biotronik Fortress Introducer Sheath System 6F; 45 cm; straightRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04251244503703), received between Sep 24, 2024 and Nov 18, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Stretched” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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 18, 2026.

Recalls naming this device

1. Jul 30, 2025Class IIOpen, Classified

   Units may have been packaged with an incorrect pouch label, which lists the reference number and unique device identifier of the 4F version of the device, rather than the packaged 6F version.

   Z-2532-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

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.

• MalfunctionNov 18, 2024Stretched; Stretched

  THE PROBLEM WAS DESCRIBED AS: "IT WAS A LEFT CFA PUNCTURE FOR A RIGHT LEG ANGIOGRAM. UPON REMOVAL OF THE FORTRESS 6F 45CM SHEATH RESISTANCE WAS ENCOUNTERED. SHEATH WAS ATTEMPTED TO BE WITHDRAWN, BUT IT WAS NOTED THAT THE SHEATH WAS STRETCHING. UPON REALIZATION, A 6F 65CM FORTRESS WAS OPENED, IN ORDER TO GET THE 65CM INTRODUCER. IT WAS MANAGED TO INSERT THE INTRODUCER INTO THE SHEATH AND REMOVED IT. NB: CLINICAL NURSE STATED THAT THE DELIVERY OF THE SHEATH OVER THE ILIAC BIFURCATION WAS UNEVENTFUL. FORTRESS VALVE AND SIDE PORT WERE REPLACED WITH A COOK VALVE AND SIDE PORT, AS THERE HAD BEEN A SEPARATE ISSUE WITH OTHER COMPANIES STENT ACCIDENTLY DEPLOYING IN THE FORTRESS SHEATH. THEREFORE, THIS PART OF THE FORTRESS SHEATH NEEDED TO BE REMOVED AND REPLACED. THIS EVENT OCCURRED WELL BEFORE THE ATTEMPT TO REMOVE THE FORTRESS SHEATH." EVENT OCCURRED: INSIDE PATIENT PATIENT INJURY: NO PATIENTS OUTCOME: DISCHARGED AT HOME. ON 23.10.2024 CUSTOMER PROVIDED ADDITIONAL INFORMATION: "I HAVE SPOKEN WITH THE SCRUB NURSE WHO SAID THAT THE 6F FORTRESS 45CM SHEATH DISTAL END WAS IN THE AORTA WHEN THEY ENCOUNTERED RESISTANCE WHEN PULLING BACK THE SHEATH. THEY WERE REMOVING IT WITHOUT THE DILATOR WHIC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20703826 ↗
• MalfunctionSep 24, 2024Unsealed Device Packaging; Unsealed Device Packaging

  THE PROBLEM WAS DESCRIBED AS: "THE FORTRESS INTRODUCER SHEATH IS NOT SEALED AT THE LOWER END. THE SHEATH IS NOT SEALED AT THE BOTTOM. THIS MEANS THAT WHEN THE SHEATH IS HANDED OVER AND THE OUTER NON-STERILE PACKAGING IS OPENED TO OPEN THE STERILE PACKAGING, THE SHEATH FALLS OUT BY ITSELF... THE BOTTOM SEAL IS MISSING. NOTHING HAS HAPPENED NOW... THE SHEATHS JUST COULDN'T BE USED BECAUSE THEY WERE NO LONGER STERILELY PACKAGED AND SOME OF THEM HAD FALLEN TO THE FLOOR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20290017 ↗