Biotronik Fortress Introducer Sheath System 45 cm, 6F CrossoverRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04251244500092), received between Nov 24, 2017 and Apr 9, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K153197); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 9, 2021Entrapment of Device; Difficult to Remove; Material Deformation; Entrapment of Device; Difficult to Remove; Material Deformation

  FOLLOWING PROBLEM DESCRIPTION WAS PROVIDED TO CMI BY THE MEDWATCH 3500A FORM 4100070000-2021-8011: TOWARDS END OF ANGIOGRAM, SURGEON HAD DIFFICULTY REMOVING 6FR FORTRESS SHEATH FROM PATIENT´S RIGHT FEMORAL ARTERY. NEW DILATOR GIVEN PER SURGEON REQUEST. SURGEON ABLE TO REMOVE SHEATH. SHEATH APPEARED TO HAVE DAMAGE TO OUTSIDE MATERIAL, A MALFUNCTION. X-RAY TECH NOTIFIED. SURGEON STATES ALL PARTS FROM DAMAGED SHEATH ACCOUNTED FOR. NO SHEATH PARTS LEFT IN PATIENT. DAMAGED SHEATH W/DILATOR WAS PLACED IN BIOHAZARDOUS BAG ALONG WITH 2ND SHEATH THAT WAS OPENED. DEFECTIVE DEVICE GIVEN TO X-RAY TECH. THE END USER DESCRIBED THE PROBLEM AS: DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11639879 ↗
• MalfunctionMar 9, 2021Break; Difficult to Remove

  TOWARDS END OF ANGIOGRAM, SURGEON HAD DIFFICULTY REMOVING 6FR FORTRESS SHEATH FROM PATIENT'S RIGHT FEMORAL ARTERY. NEW DILATOR GIVEN PER SURGEON REQUEST. SURGEON ABLE TO REMOVE SHEATH. SHEATH APPEARED TO HAVE DAMAGE TO OUTSIDE MATERIAL, A MALFUNCTION. X-RAY TECH NOTIFIED. SURGEON STATES ALL PARTS FROM DAMAGED SHEATH ACCOUNTED FOR. NO SHEATH PARTS LEFT IN PATIENT. DAMAGED SHEATH W/DILATOR WAS PLACED IN BIOHAZARDOUS BAG ALONG WITH 2ND SHEATH THAT WAS OPENED. DEFECTIVE DEVICE GIVEN TO X-RAY TECH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11444786 ↗
• MalfunctionJul 24, 2020Entrapment of Device; Difficult to Remove; Material Integrity Problem; Entrapment of Device; Difficult to Remove; Material Integrity Problem

  FOLLOWING PROBLEM DESCRIPTION WAS PROVIDED TO CMI BY THE CUSTOMER THRU COMPLAINT NOTIFICATION FORM: "DURING RETRACTION OF THE SHEATH, A MATERIAL FRACTURE OCCURRED JUST BEHIND THE HEMOSTATIC VALVE. ALL PARTS OF THE SHEATH COULD BE REMOVED. THE PATIENT WAS NOT INJURED."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10319049 ↗
• MalfunctionNov 24, 2017Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove

  THE FOLLOWING INCIDENT DESCRIPTION WAS REPORTED BY THE CUSTOMER: "A FORTRESS 6F INTRODUCER SHEET WAS PERFORMING NORMALLY DURING A PTA CROSSOVER INTERVENTION. DURING REMOVAL OF THE SHEET THE INTERVENTIONAL PHYSICIAN (B)(6) HAD A HARD TIME TO COMPLETE THE PROCEDURE. THE SHEET ELONGATED ITSELF AND WAS FINALLY REMOVED IN ONE PIECE. THERE WAS NO COMPLICATION TO THE PATIENT OR ANY PARTS REMAINED IN THE BODY."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7057617 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K153197. One submission often covers many models, so check the product and lot details in each record.

• Z-2532-2025 · Jul 30, 2025 · Open, Classified
  Brand Name: Fortress Introducer Sheath System Product Name: Fortress Introducer Sheath System Model/Catalog Number: 386594 Product Description: Fortress Introducer Sheath System, 6