Biotronik Fortress Introducer Sheath System 4F; 45 cm; 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 04251244503604), received between Feb 5, 2025 and Feb 5, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Break1
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.
MalfunctionFeb 5, 2025Break; Break
THE PROBLEM WAS DESCRIBED AS: "DURANT UNE INTERVENTION ENDOVASCULAIRE, NOUS AVONS UTILISÉ DEUX INTRODUCTEURS DE 4F LONGS FORTRESS (MÊME LOT: 800441), LE PREMIER ÉTAIT DÉFECTUEUX CAR LE MANDRIN DE RENTRAIT PAS AISÉMENT DANS L'INTRODUCTEUR ET LE DEUXIÈME S'EST COMPLÈTEMENT DÉTRUIT LORSQUE LA CHIRURGIENNE A TENTÉ DE LE RETIRER DE L'ARTÈRE ILIAQUE GAUCHE. IL NOUS SEMBLE QUE LE DISPOSITIF EST COMPLÈTEMENT RESSORTI, BIEN QUE EN PLUSIEURS MORCEAUX MAIS POSSIBILITÉ DE DÉBRIS RESTANTS DANS LA PATIENTE. DURING AN ENDOVASCULAR PROCEDURE, WE USED TWO FORTRESSES LONG 4F INTRODUCERS (SAME LOT: 800441), THE FIRST OF WHICH WAS DEFECTIVE BECAUSE THE DILATOR DID NOT FIT EASILY INTO THE INTRODUCER AND THE SECOND WAS COMPLETELY DESTROYED WHEN THE SURGEON TRIED TO REMOVE IT FROM THE LEFT ILIAC ARTERY. IT SEEMS TO US THAT THE DEVICE CAME OUT COMPLETELY, ALBEIT IN SEVERAL PIECES, BUT THERE IS A POSSIBILITY OF DEBRIS REMAINING IN THE PATIENT." L'INCIDENT A-T-IL EFFECTIVEMENT EU DES CONSÉQUENCES GRAVES POUR LE PATIENT, L'UTILISATEUR OU UN TIERS? NON. DID THE INCIDENT HAVE SERIOUS CONSEQUENCES FOR THE PATIENT, USER OR THIRD PARTY? NO. VEUILLEZ DÉCRIRE LES CONSEQUENCES GRAVES POSSIBLES ET INDIQUER LA RAISON
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21312444 ↗
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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