Biotronik Fortress Introducer Sheath System 65 cm, 5F StraightRecalls & reported problems
Contract Medical International GmbH · Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1) dilator. · Class 2
All models of Biotronik Fortress Introducer Sheath System (12)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04251244500573), received between Jun 22, 2022 and Jun 22, 2022 — classified as 1 death.
The most frequently reported specific device problem is “Difficult to Remove” (1 report).
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
Device problems
- Difficult to Remove1
- Entrapment of Device1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathJun 22, 2022Entrapment of Device; Difficult to Remove; Material Separation; Entrapment of Device; Difficult to Remove; Material Separation
DR (B)(6) USED A FORTRESS 5 X 65 SHEATH (ITEM NUMBER: 444484, LOT: 686650); AS THE INTRODUCING SHEATH WAS BEING REMOVED FOR CLOSURE, DR (B)(6) REALIZED THE BIOTRONIK SHEATH FRAYED (WAS COMING APART) INSIDE THE PATIENT, WHICH REQUIRED DOUBLE ACCESS IN AN ATTEMPT TO SNARE, A QUICK DECOMPENSATION OF THE PATIENT WHICH REQUIRED A CALL TO 911 AND TRANSFER TO EMERGENCY ROOM. THIS DEVICE HAS BEEN SAVED FOR YOU FOR FURTHER INVESTIGATION. USED A TURBO LASER 1.4 FOR THE ATHERECTOMY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14774472 ↗
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, ClassifiedBrand Name: Fortress Introducer Sheath System Product Name: Fortress Introducer Sheath System Model/Catalog Number: 386594 Product Description: Fortress Introducer Sheath System, 6
Other Introducer, Catheter devices
- VIZIGO D138502Biosense Webster Inc · INTRODUCER, CATHETER2 recalls4 deaths2,839 reports
- VIZIGO D138501Biosense Webster Inc · INTRODUCER, CATHETER2 recalls2 deaths2,005 reports
- Swartz™ 407451St. Jude Medical, Inc. · INTRODUCER, CATHETER5 deaths728 reports
- Edwards eSheath+ Introducer set 914ESPEdwards Lifesciences LLC · Introducer, Catheter22 deaths532 reports
- Fast-Cath™ 406849St. Jude Medical, Inc. · INTRODUCER, CATHETER420 reports
- VIZIGO D138503Biosense Webster Inc · INTRODUCER, CATHETER362 reports
- Agilis™ G408318St. Jude Medical, Inc. · INTRODUCER, CATHETER333 reports
- Agilis™ NxT Steerable Introducer Dual-Reach™ SI-1371-MSt. Jude Medical, Inc. · Introducer, catheter1 death301 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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