DuraMax® (REF H787103028045)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00884450786161), received between Mar 7, 2025 and Mar 24, 2026 — classified as 1 death, 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (2 reports).

1 FDA recall record name this device's 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Feb 13, 2026Open, Classified

   16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access.

   Z-1578-2026 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2026Separation Problem

  THE CUSTOMER REPORTS THAT WHEN USING THE DURAMAX, THE STAFF AND PHYSICIANS WERE UNABLE TO EASILY DETACH FROM THE PEEL AWAY SHEATH. THE CATHETER WAS ALREADY IMPLANTED IN THE PATIENT AND UPON REMOVAL, THE SHEATH WOULD NOT DETACH. ALL THE OTHER COMPONENTS OF THE KIT WORKED, WITH THE THIS BEING ONE OF THE LAST STEPS IN THE PROCESS, THE TEAM JUST MADE IT WORK SO THEY DIDN'T HAVE TO REDO THE WHOLE PROCESS AGAIN ON THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24680251 ↗
• MalfunctionMar 24, 2026Separation Failure

  THE CUSTOMER REPORTS THAT THE PEEL AWAY SHEATH WOULD NOT PEEL PROPERLY RESULTING IN OPENING ADDITIONAL SUPPLIES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24673896 ↗
• InjuryMar 12, 2026Fracture

  THE ACCOUNT ALLEGES THAT DURING DEVICE REMOVAL THROUGH THE SKIN TRACT, THE METAL COMPONENT SEPARATED FROM THE PLASTIC SLEEVE AND REMAINED UNDER THE PATIENT'S SKIN. THE RETAINED COMPONENT WAS MANUALLY RETRIEVED. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24582981 ↗
• InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT DURING THE PLACEMENT OF THE PERMANENT CATHETER, AT THE TIME OF INSERTION USING THE SELDINGER TECHNIQUE, WHEN THE GUIDE IS REMOVED, THE CATHETER IS RETURNED TOGETHER, CAUSING A HEMOTHORAX TO THE PATIENT DURING THE PROCEDURE.

  Patient problems: Hemothorax

  MAUDE report 24429252 ↗
• DeathMar 26, 2025Difficult to Remove; Material Separation; Separation Failure; Activation, Positioning or Separation Problem; Difficult to Remove; Material Separation; Separation Failure; Activation, Positioning or Separation Problem

  MW5166325 THE ACCOUNT ALLEGES THAT A 55-YEAR-OLD MALE PATIENT WAS ADMITTED ON (B)(6) 2024, "STATUS POST" [S/P] SEPSIS DUE TO PNEUMONIA. ON (B)(6) 2024, THE PATIENT ARRIVED IN IR [INTERVENTIONAL RADIOLOGY] FOR A TUNNELED HEMODIALYSIS CATHETER PLACEMENT. PER RADIOLOGY NOTE: "THE PATIENT HAD 02 DESATURATIONS IMMEDIATELY AFTER PLACEMENT OF A TUNNELED HD CATHETER". THE TEAR-AWAY PORTION OF THE SHEATH HAD ALLEGEDLY MALFUNCTIONED, AND THE PHYSICIAN HAD TO REMOVE THE HD CATHETER, RESULTING IN A SUSPECTED AIR EMBOLUS. A RAPID RESPONSE WAS CALLED. THE PATIENT WAS PLACED IN THE LEFT LATERAL POSITION (LLP), WHERE SUPPLEMENTAL OXYGEN WAS ADMINISTERED. THE PHYSICIAN SUSPECTED A COMPONENT OF AN AIR EMBOLISM VERSUS OBSTRUCTIVE AIRWAY OR A COMBINATION OF BOTH. EVENTUALLY, THE PATIENT'S OXYGEN SATURATIONS IMPROVED WITH THE NON-REBREATHER MASK [NRM]. THE PATIENT WAS TRANSFERRED BACK TO THE ICU ON 100% OXYGEN AND STILL REQUIRED INTUBATION TUBE PLACEMENT DUE TO A COMPROMISED AIRWAY FROM ATTEMPTS AT PLACING A NASAL TRUMPET TO ASSIST WITH THE BAG-VALVE-MASK RESPIRATIONS. THE NASAL TRUMPET PLACED IN THE RIGHT NOSTRIL DURING THE PROCEDURE LED TO EPISTAXIS. CXR DEMONSTRATED "DIFFUSE BILATERAL AIRSPACE DISEA

  Patient problems: Air Embolism; Airway Obstruction; Bacterial Infection; Brain Injury; Cardiac Arrest; Convulsion/Seizure; Decreased Respiratory Rate; Epistaxis; Hemorrhage/Blood Loss/Bleeding; Hypoxia; Low Oxygen Saturation; Obstruction/Occlusion; Pulmonary Dysfunction; Twitching; Ventilator Dependent

  MAUDE report 21704293 ↗
• InjuryMar 26, 2025Difficult or Delayed Separation; Difficult or Delayed Separation

  THE ACCOUNT ALLEGES THE SHEATH DID NOT PEEL DOWN THE MIDDLE AS NORMAL. ONE SIDE PEELED PARTIALLY AND THEN BROKE ABOUT ONE THIRD OF THE WAY DOWN. ALL OF THE PEEL AWAY SHEATH WAS ABLE TO BE REMOVED FROM THE PATIENT AFTER IT MALFUNCTIONED. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21700183 ↗
• MalfunctionMar 19, 2025Material Integrity Problem; Material Integrity Problem

  THE ACCOUNT ALLEGES THE INTRODUCER FAILED TO SPLIT CLEANLY. WITH AN EXTRA PEEL WAY, EXTRA WIRE, AND A MICRO PUNCTURE SET THEY WERE ABLE TO KEEP ACCESS AND PREVENT AN AIR EMBOLUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21644413 ↗
• MalfunctionMar 11, 2025Difficult to Remove; No Apparent Adverse Event; Difficult to Remove; No Apparent Adverse Event

  THE CUSTOMER REPORTS THAT DURING PLACEMENT, THE SHEATH WOULDN'T BREAK APART EVENLY. TOOLS WERE USED TO DISSECT THE REMAINING PEEL AWAY SHEATH WHEN IT BROKE UNEVENLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21578793 ↗
• MalfunctionMar 7, 2025Material Separation; No Apparent Adverse Event; Material Separation; No Apparent Adverse Event

  ADDITIONAL REPORT RECEIVED ON MEDWATCH MW5166355.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21554481 ↗