Biotronik Fortress Introducer Sheath System 6F; 45 cm; crossoverRecalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04251244503727), received between Oct 25, 2024 and Feb 24, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break1
- Difficult to Remove1
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 24, 2026Fluid/Blood Leak
EVENT DETAILS: DURING THE PROCEDURE, IT WAS OBSERVED THAT THE HEMOSTATIC VALVE DID NOT SEAL COMPLETELY. WHEN ADDITIONAL GUIDEWIRES, BALLOONS, OR OTHER INSTRUMENTS WERE INTRODUCED, EXCESSIVE BLOOD FLOW OCCURRED. AS THIS ISSUE HAS NOW APPEARED FOR THE THIRD TIME WITHIN THE SAME LOT, THE ENTIRE LOT HAS BEEN COLLECTED FOR FURTHER INSPECTION. PRODUCTS THAT WERE USED INSIDE PATIENTS WILL NOT BE RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24434372 ↗MalfunctionOct 25, 2024Break; Difficult to Remove; Break; Difficult to Remove
THE 6FR FORTRESS SHEATH WAS ATTEMPTED TO BE REMOVED BUT WAS FOUND TO HAVE RESISTANCE. THE SHEATH WAS NOTED TO HAVE BROKEN WHILE IN THE VESSEL. DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING). PATIENT INJURY: NO. DID DEVICE PARTS REMAIN IN THE PATIENT? NO. EVENT OCCURRED: INSIDE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20531400 ↗
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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