Biotronik Fortress Introducer Sheath System 100 cm, 6F StraightRecalls & reported problems
Contract Medical International GmbH · Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and Two (2) dilators. · 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
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04251244500085), received between Feb 12, 2019 and Feb 12, 2019 — classified as 1 malfunction.
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 Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 12, 2019Entrapment of Device; Difficult to Remove; Material Separation; Entrapment of Device; Difficult to Remove; Material Separation
UPON FINISHING A CASE PROVIDER WAS REMOVING THE LONG SHEATH FROM INSIDE THE BODY. PHYSICIAN MET HEAVY RESISTANCE UPON REMOVAL. PHYSICIAN THEN NOTICED THE SHEATH HAD FRAYED AND EVENTUALLY BROKE OFF IN THE BODY WHEN MANUAL PRESSURE HAD TO BE APPLIED TO CONTROL BLEEDING. PATIENT WAS ADMITTED FOR PLANNED INTERVENTION OF LEFT CHRONIC OCCLUSION OF POPLITEAL ARTERY. PTA UNSUCCESSFUL. UPON REMOVAL OF SHEATH, SHEATH DEGRADED. ADVANCED WITHOUT DIFFICULTY. EMERGENCY CUT-DOWN PERFORMED OF BILATERAL GROINS, SHEATH REMOVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8331226 ↗
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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