Biotronik Fortress Introducer Sheath System 90 cm, 6F StraightRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04251244500603), received between May 19, 2023 and Jun 22, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 22, 2023Fracture; Difficult to Remove; Material Separation; Detachment of Device or Device Component; Fracture; Difficult to Remove; Material Separation; Detachment of Device or Device Component

  HEAVILY CALCIFIED ILIACS. (B)(6) ADVANCED THE FORTRESS 6X90 SHEATH AND WAS ABLE TO COMPLETE THE INTERVENTION OF THE THREE TARGET LESIONS/VESSELS (RIGHT POP, PERONEAL AND PTA). UPON COMPLETION OF THE CASE (B)(6) REMOVED THE FORTRESS SHEATH BUT THE LAST 10CM BROKE OFF INSIDE OF THE PATIENT IN THE COMMON FEMORAL ARTERY. (B)(6) ADVISED THERE WAS A LOT OF SCAR TISSUE IN THE COMMON FEMORAL. THE PATIENT HAD TO BE TAKEN TO THE HOSPITAL FOR OPEN SURGERY TO REMOVE THE 10CM OF THE FORTRESS SHEATH THAT BROKE OFF. SURGERY WAS SUCCESSFUL AND THE BROKEN PIECE OF THE SHEATH WAS REMOVED. VESSEL TORTUOSITY: MODERATE. CALCIFICATION OF VESSEL: SEVERE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17182048 ↗
• MalfunctionMay 19, 2023Fracture; Difficult to Remove; Material Separation; Detachment of Device or Device Component; Fracture; Difficult to Remove; Material Separation; Detachment of Device or Device Component

  PER HEALTH CARE PROFFESIONAL OF BAPTIST ST ANTHONYS, WE THEN USED A 6 FRENCH PLANTARIS ATHERECTOMY DEVICE TO DEBULK THE MAJORITY OF THE PLAQUE INTO THE ATA. FOLLOWING THIS WE USED A 3 MM BALLOON TO PERFORM BALLOON ENTEROPLASTY OF THE PROXIMAL ATA. THE SHEATH WAS PARTIALLY OCCLUSIVE. UPON TRYING TO PULL IT BACK, THE SHEATH CAME APART OUTSIDE OF THE BODY-FORTUNATELY. WHEN ATTEMPTING TO PULL IT BACK FROM THE REMAINING PIECE OF SHEET IT ALSO FRACTURED. FOLLOWING THIS WE USED MANUAL PRESSURE AT THE GROIN AND PINCHED THE SHEATH OFF. WE THEN REMOVED THE COMMAND WIRE AND ADVANCED A ADVANTAGE GLIDEWIRE (0.35) THROUGH THE FRACTURED SHEATH INTO THE DISTAL POPLITEAL ARTERY. I WAS ABLE TO NAVIGATE A 4 MM BALLOON THROUGH THE FRACTURE SHEATH TO THE DISTAL EDGE OF THE SHEATH. THE BALLOON WAS INFLATED TO SECURE IT TO THE SHEATH AT THE DISTAL EDGE. THE BALLOON WAS USED TO ADD SUPPORT AND WITHDRAWING THE SHEATH FROM THE BODY WHILE LEAVING THE BANDAGE GLIDEWIRE AND THE LEFT FEMORAL ARTERY. ONCE THE SHEATH WAS REMOVED, WE PLACED A 45 CM 6 FRENCH TERUMO SHEATH. VESSEL TORTUOSITY: MODERATE. CALCIFICATION: SEVERE. PREDILATION. YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16961701 ↗

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