Biotronik Fortress Introducer Sheath SystemRecalls & reported problems across all models

We found 12 models of Biotronik Fortress Introducer Sheath System by Contract Medical International GmbH in the FDA's device registry (GUDID). Together they are named in 24 adverse event reports in the FDA's MAUDE database, received between Nov 24, 2017 and Feb 24, 2026 — classified as 1 death, 23 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (18 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Biotronik Fortress Introducer Sheath System recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jul 30, 2025Class IIOpen, Classified

   Units may have been packaged with an incorrect pouch label, which lists the reference number and unique device identifier of the 4F version of the device, rather than the packaged 6F version.

   Z-2532-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported Biotronik Fortress Introducer Sheath System problems

Biotronik Fortress Introducer Sheath System models

12 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Biotronik Fortress Introducer Sheath System 6F; 45 cm; straight

  Introducer, Catheter
  1 recall2 reports
• Biotronik Fortress Introducer Sheath System 45 cm, 6F Straight

  Introducer, Catheter
  5 reports
• Biotronik Fortress Introducer Sheath System 45 cm, 6F Crossover

  Introducer, Catheter
  4 reports
• Biotronik Fortress Introducer Sheath System 45 cm, 4F Straight

  Introducer, Catheter
  3 reports
• Biotronik Fortress Introducer Sheath System 90 cm, 6F Straight

  Introducer, Catheter
  2 reports
• Biotronik Fortress Introducer Sheath System 6F; 45 cm; crossover

  Introducer, Catheter
  2 reports
• Biotronik Fortress Introducer Sheath System 45 cm, 5F Straight

  Introducer, Catheter
  1 report
• Biotronik Fortress Introducer Sheath System 100 cm, 6F Straight

  Introducer, Catheter
  1 report
• Biotronik Fortress Introducer Sheath System 65 cm, 5F Straight

  Introducer, Catheter
  1 death1 report
• Biotronik Fortress Introducer Sheath System 90 cm, 5F Straight

  Introducer, Catheter
  1 report
• Biotronik Fortress Introducer Sheath System 7F, 45cm, Straight

  Introducer, Catheter
  1 report
• Biotronik Fortress Introducer Sheath System 4F; 45 cm; straight

  Introducer, Catheter
  1 report

Recent Biotronik Fortress Introducer Sheath System adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• MalfunctionNov 18, 2024Stretched; Stretched

  THE PROBLEM WAS DESCRIBED AS: "IT WAS A LEFT CFA PUNCTURE FOR A RIGHT LEG ANGIOGRAM. UPON REMOVAL OF THE FORTRESS 6F 45CM SHEATH RESISTANCE WAS ENCOUNTERED. SHEATH WAS ATTEMPTED TO BE WITHDRAWN, BUT IT WAS NOTED THAT THE SHEATH WAS STRETCHING. UPON REALIZATION, A 6F 65CM FORTRESS WAS OPENED, IN ORDER TO GET THE 65CM INTRODUCER. IT WAS MANAGED TO INSERT THE INTRODUCER INTO THE SHEATH AND REMOVED IT. NB: CLINICAL NURSE STATED THAT THE DELIVERY OF THE SHEATH OVER THE ILIAC BIFURCATION WAS UNEVENTFUL. FORTRESS VALVE AND SIDE PORT WERE REPLACED WITH A COOK VALVE AND SIDE PORT, AS THERE HAD BEEN A SEPARATE ISSUE WITH OTHER COMPANIES STENT ACCIDENTLY DEPLOYING IN THE FORTRESS SHEATH. THEREFORE, THIS PART OF THE FORTRESS SHEATH NEEDED TO BE REMOVED AND REPLACED. THIS EVENT OCCURRED WELL BEFORE THE ATTEMPT TO REMOVE THE FORTRESS SHEATH." EVENT OCCURRED: INSIDE PATIENT PATIENT INJURY: NO PATIENTS OUTCOME: DISCHARGED AT HOME. ON 23.10.2024 CUSTOMER PROVIDED ADDITIONAL INFORMATION: "I HAVE SPOKEN WITH THE SCRUB NURSE WHO SAID THAT THE 6F FORTRESS 45CM SHEATH DISTAL END WAS IN THE AORTA WHEN THEY ENCOUNTERED RESISTANCE WHEN PULLING BACK THE SHEATH. THEY WERE REMOVING IT WITHOUT THE DILATOR WHIC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20703826 ↗
• 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 ↗
• MalfunctionSep 24, 2024Unsealed Device Packaging; Unsealed Device Packaging

  THE PROBLEM WAS DESCRIBED AS: "THE FORTRESS INTRODUCER SHEATH IS NOT SEALED AT THE LOWER END. THE SHEATH IS NOT SEALED AT THE BOTTOM. THIS MEANS THAT WHEN THE SHEATH IS HANDED OVER AND THE OUTER NON-STERILE PACKAGING IS OPENED TO OPEN THE STERILE PACKAGING, THE SHEATH FALLS OUT BY ITSELF... THE BOTTOM SEAL IS MISSING. NOTHING HAS HAPPENED NOW... THE SHEATHS JUST COULDN'T BE USED BECAUSE THEY WERE NO LONGER STERILELY PACKAGED AND SOME OF THEM HAD FALLEN TO THE FLOOR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20290017 ↗
• MalfunctionFeb 8, 2024Loss of or Failure to Bond; Material Separation; Detachment of Device or Device Component; Loss of or Failure to Bond; Material Separation; Detachment of Device or Device Component

  THE CUSTOMER REPORTED AS FOLLOWS: "LITTLE GREEN CAP WITH HOLE IN MIDDLE ON THE SIDE OF THE DEVICE POPPED OFF DURING PROCEDURE. BECAUSE OF THIS, A LOT OF BLOOD WAS LOST AND A TRANSFUSION HAD TO BE DONE." EVENT OCCURRED INSIDE PATIENT. DEVICE PARTS DIDN'T REMAIN IN THE PATIENT. THERE IS PATIENT INJURY AND BLOOD TRANSFUSION NEEDED, DUE TO LOSS OF BLOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18668382 ↗
• MalfunctionNov 20, 2023Fracture; Material Separation; Detachment of Device or Device Component; Fracture; Material Separation; Detachment of Device or Device Component

  DURING REMOVAL OF A BIOTRONIK FORTRESS 7F 45CM INTRODUCER, THE SHEATH "DISINTEGRATED" WHEN IT WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18169787 ↗
• 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 ↗
• 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 ↗
• MalfunctionJan 18, 2022Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  THE CUSTOMER REPORTED: THE SHEATH CAME APART INSIDE PATIENT. THE SHEATH WAS RETRIEVED WITH AN AURYON CATHETER. NO PATIENT INJURY HAD OCCURRED VERIFIED BY X-RAY. TREATED VESSEL: RIGHT SFA (SUPERFICIAL FEMORAL ARTERY), REFERENCE DIAMETER 4MM, STENOSIS DEGREE: 50%, VESSEL TORTUOSITY: MODERATE, CALCIFICATION: MILD. PRE-DILATATION: NO. FINAL PATIENT´S OUTCOME: DISCHARGED HOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13278750 ↗
• MalfunctionApr 9, 2021Entrapment of Device; Difficult to Remove; Material Deformation; Entrapment of Device; Difficult to Remove; Material Deformation

  FOLLOWING PROBLEM DESCRIPTION WAS PROVIDED TO CMI BY THE MEDWATCH 3500A FORM 4100070000-2021-8011: TOWARDS END OF ANGIOGRAM, SURGEON HAD DIFFICULTY REMOVING 6FR FORTRESS SHEATH FROM PATIENT´S RIGHT FEMORAL ARTERY. NEW DILATOR GIVEN PER SURGEON REQUEST. SURGEON ABLE TO REMOVE SHEATH. SHEATH APPEARED TO HAVE DAMAGE TO OUTSIDE MATERIAL, A MALFUNCTION. X-RAY TECH NOTIFIED. SURGEON STATES ALL PARTS FROM DAMAGED SHEATH ACCOUNTED FOR. NO SHEATH PARTS LEFT IN PATIENT. DAMAGED SHEATH W/DILATOR WAS PLACED IN BIOHAZARDOUS BAG ALONG WITH 2ND SHEATH THAT WAS OPENED. DEFECTIVE DEVICE GIVEN TO X-RAY TECH. THE END USER DESCRIBED THE PROBLEM AS: DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11639879 ↗
• MalfunctionApr 8, 2021Difficult to Remove; Material Separation; Material Deformation; Difficult to Remove; Material Separation; Material Deformation

  FOLLOWING PROBLEM DESCRIPTION WAS PROVIDED BY THE CUSTOMER: "DR. (B)(6) USED A FORTRESS SHEATH TO TREAT A PATIENT WITH PERIPHERAL VASCULAR DISEASE. AFTER DELIVERING A STENT AND MULTIPLE BALLOONS, HE COMPLETED THE CASE. AS HE TRIED TO PULL THE FORTRESS OUT OF THE ARTERY, HE ENCOUNTERED A LOT OF RESISTANCE. THERE WAS SIGNIFICANT SCAR TISSUE FROM PREVIOUS CASES. THE PLASTIC SHEATH BROKE INTO TWO PIECES, BUT THE METAL COIL KEPT ALL OF THE PIECES TOGETHER AND THE DOC WAS ABLE TO REMOVE THE SHEATH, INTACT. SHEATH WILL BE AVAILABLE FOR REVIEW FROM THE HOSPITAL ONCE THEY ARE DONE WITH IT, PER THEIR PROTOCOLS. TREATED VESSEL: RIGHT COMMON FEMORAL. NO DEVICE PARTS REMAINED IN THE PATIENT. FINAL PATIENT´S OUTCOME: DISCHARGED HOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11632638 ↗
• MalfunctionMar 9, 2021Break; Difficult to Remove

  TOWARDS END OF ANGIOGRAM, SURGEON HAD DIFFICULTY REMOVING 6FR FORTRESS SHEATH FROM PATIENT'S RIGHT FEMORAL ARTERY. NEW DILATOR GIVEN PER SURGEON REQUEST. SURGEON ABLE TO REMOVE SHEATH. SHEATH APPEARED TO HAVE DAMAGE TO OUTSIDE MATERIAL, A MALFUNCTION. X-RAY TECH NOTIFIED. SURGEON STATES ALL PARTS FROM DAMAGED SHEATH ACCOUNTED FOR. NO SHEATH PARTS LEFT IN PATIENT. DAMAGED SHEATH W/DILATOR WAS PLACED IN BIOHAZARDOUS BAG ALONG WITH 2ND SHEATH THAT WAS OPENED. DEFECTIVE DEVICE GIVEN TO X-RAY TECH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11444786 ↗
• MalfunctionNov 9, 2020Entrapment of Device; Difficult to Remove; Material Separation; Material Deformation; Entrapment of Device; Difficult to Remove; Material Separation; Material Deformation

  FOLLOWING PROBLEM DESCRIPTION WAS PROVIDED TO CMI BY THE CUSTOMER, "THE CATHETER CAME APART DURING REMOVAL. IT WAS SAID THERE WAS SCAR TISSUE AT BIFURCATION. 0.35 WIRE WAS IN CATHETER DURING REMOVAL." "THE FORTRESS WAS PINCHED AND CAME APART AFTER THAT CREASE. A CROSSING CATHETER WAS PLACED OVER THE WIRE AND THE FORTRESS WAS ABLE TO BE REMOVED FROM THE BODY. THE FORTRESS FLUSHED PROPERLY BEFORE ENTERING THE BODY AND THE INTEGRITY SEEMED NORMAL." NAME OF PROCEDURE: ANGIO L LEG WITH ATHERECTOMY (BOSTON SCIENTIFIC ROTABLATOR 1.25) AND BALLOON ANGIOPLASTY; TREATED VESSEL: DISTAL SFA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10807695 ↗

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