Intri24 Introducer Sheath 52-101Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00850291007260), received between Sep 22, 2022 and Mar 5, 2026 — classified as 1 death, 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

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

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 5, 2026Fluid/Blood Leak

  ON (B)(6) 2026 A PATIENT UNDERWENT PULMONARY EMBOLISM (PE) THROMBECTOMY USING INARI DEVICES. THE PATIENT WAS A SUBJECT IN THE PERSERVE CLINICAL TRIAL. DURING THE THROMBECTOMY, CLOT WAS STUCK IN THE TRIEVER24 (T24) WHERE THE DEVICE HAD TO BE REMOVED FROM THE PATIENT TO REMOVE THE CLOT FROM THE DEVICE. IT WAS NOTICED THAT THE INTRI24 INTRODUCER SHEATH (INTRI24) LEAKED WHEN THE T24 WAS REMOVED FROM THE INTRI24 AND T24 WAS REMOVED SEVERAL TIMES DURING THE PROCEDURE TO CLEAN CLOT FROM THE DEVICE. THIS LEAKAGE LED TO BLEEDING WHERE THE PATIENT REQUIRED A TRANSFUSION OF TWO UNITS OF BLOOD. THE SITE ALSO NOTED THE PATIENT SUFFERED PRE-PROCEDURE HYPOTENSION AND DESATURATION WHICH RESULTED IN LOW BLOOD PRESSURE DURING THE THROMBECTOMY WHICH RESOLVED WITH MEDICATION AND THE PATIENT ALSO SUFFERED CARDIAC ARREST AND WAS TREATED WITH MEDICATION INTERVENTION.

  Patient problems: Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension

  MAUDE report 24524394 ↗
• InjuryOct 15, 2025Use of Device Problem; Use of Device Problem

  ON (B)(6) 2025, A MALE PATIENT UNDERWENT PULMONARY EMBOLISM (PE) THROMBECTOMY USING INARI DEVICES. THE PATIENT HAD A SADDLE PE. DURING THE THROMBECTOMY, A LARGE AMOUNT OF BLOOD HAD LEAKED FROM AROUND THE INTRI24 INTRODUCER SHEATH (INTRI24), THEREFORE THE MEDICAL TEAM REPLACED THE DEVICE WITH A NEW INTRI24, HOWEVER THE SECOND INTRI24 EXPERIENCED THE SAME ISSUE. THE LEAK WAS NOTICED WHEN THE DILATOR WAS REMOVED. WHEN ASKED ABOUT THE STEPS TAKEN TO PLACE THE INTRI24, THE PHYSICIAN DESCRIBED FLOATING THE INTRI24 IN THE INFERIOR VENA CAVA (IVC) AND INTRODUCING THE SHEATH OVER THE FLOATING WIRE. THE PHYSICIAN RAN A CATHETER INTO THE ILIAC ARTERY NEAR THE ENTRANCE OF THE INTIR24 AND INJECTED CONTRAST. THE ARTERY WAS INTACT WITH NO SIGNS OF PERFORATION. THEN A SHEATH WAS INTRODUCED SIDE-BY-SIDE WITH THE INTRI24 AND CONTRAST WAS INJECTED AGAIN, SHOWING NO SIGNS OF ILIAC OR FEMORAL VEIN EXTRAVASATION. CONTRAST WAS THEN INJECTED INTO THE PATIENT'S IVC AND SLIGHT EXTRAVASATION WAS OBSERVED. THE EXTRAVASATION WORSENED WHEN THE DILATOR AND INTRI24 WERE RETRACTED. THE INTRI24 WAS REMOVED, AND A BALLOON TAMPONADE WAS PLACED TO CONTROL THE BLEEDING. THE PATIENT'S VITALS REMAINED STABLE THROUGHOUT T

  Patient problems: Extravasation

  MAUDE report 23296676 ↗
• DeathMar 11, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  AN 85-YEAR-OLD FEMALE ARRIVED AT THE HOSPITAL WITH SHORTNESS OF BREATH AND CHEST PAIN. THE PATIENT HAD A HISTORY OF CARDIAC ISSUES AND WAS LISTED AS "DO NOT RESUSCITATE". THE PATIENT WAS DIAGNOSED WITH MASSIVE PULMONARY EMBOLISM AND A THROMBECTOMY WAS PERFORMED WITH INARI DEVICES. THE PATIENT WAS INTUBATED AND ON TWO PRESSORS AT THE BEGINNING OF THE THROMBECTOMY. THE PROCEDURE BEGAN WITHOUT ISSUES AND A LARGE AMOUNT OF CLOT WAS REMOVED FROM THE PATIENT'S RIGHT SIDE THROUGH FIVE ASPIRATIONS WITH THE TRIEVER20 (T20). THE PATIENT'S OXYGEN (O2) SATURATION ROSE, AND IMAGING REVEALED THAT THE RIGHT SIDE WAS CLEAR. THE PHYSICIAN RE-POSITIONED TO THE LEFT AND WAS IN PROCESS OF OBTAINING WIRE POSITIONING WHEN A NURSE NOTICED A LARGE VOLUME OF BLOOD ON THE GROUND. UPON FURTHER INVESTIGATION, THE STOPCOCK OF THE LARGE BORE SYRINGE SIDE PORT WAS NOT CLOSED AFTER IMAGING WAS PERFORMED. IT WAS ESTIMATED THAT THERE WAS 500 CC OF BLOOD LOST FROM THE SIDE PORT BEING LEFT OPEN. THIS WAS IN ADDITION TO 300 CC OF BLOOD LOSS FROM ASPIRATIONS LEADING TO A TOTAL OF APPROXIMATELY 800 CC OF BLOOD LOSS. THE PATIENT'S BLOOD PRESSURE AND O2 DECLINED. THE PHYSICIAN MANAGED TO RE-POSITION TO THE LEFT SIDE WHILE

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21579947 ↗
• MalfunctionOct 7, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL EVENT INFORMATION WAS REQUESTED AND IT WAS CLARIFIED THAT THERE WAS NO UNUSUAL RESISTANCE OR FORCE EXPERIENCED WHEN INSERTING THE DILATOR. INSERTION WAS MONITORED VIA FLUOROSCOPY; WHEN THE DILATOR REACHED THE FEMORAL HEAD IT APPEARED AS THOUGH THE DILATOR WAS NO LONGER MOVING AS A SINGLE UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17892509 ↗
• InjurySep 22, 2022Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  A (B)(6) FEMALE PATIENT WAS DIAGNOSED WITH A RIGHT ATRIAL (RA) CLOT-IN-TRANSIT (CIT) ADHERED AND MASSIVE BILATERAL PULMONARY EMBOLISM (PE). THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT IN CRITICAL CONDITION AND WAS PLACED ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) AND A VENTILATOR. ON (B)(6) 2022, THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL (REMAINING ON ECMO AND VENTILATOR) FOR TREATMENT. THE INITIAL SURGICAL PLAN WAS TO RETRIEVE THE RA CLOT AND THEN WIRE THE PULMONARY ARTERIES FOR PE THROMBECTOMY; THE PATIENT WAS TO REMAIN ON ECMO AND THE PERFUSIONIST WAS IN ATTENDANCE TO CLAMP THE CIRCUIT WHEN NECESSARY. ON (B)(6) 2022 THE PATIENT UNDERWENT ATTEMPTED THROMBECTOMY WITH THE INARI INTRI24 INTRODUCER SHEATH, TRIEVER24 (T24), AND TRIEVER20 (T20) CURVE. THE INTRI24 SHEATH WAS USED FOR ACCESS AND THE T24 AND T20 CURVE WERE USED FOR THROMBECTOMY OF THE RIGHT ATRIUM. TO TREAT THE ATRIAL CLOT AND TO WORK WITH THE EMCO CANNULA POSITION IN THE INFERIOR VENA CAVA, SEVERAL DEVICE EXCHANGES WERE REQUIRED, INCLUDING THE INSERTION OF A 5 FR SHEATH INTO THE INTRI24 SHEATH VALVE TO GAIN WIRE POSITION IN THE PULMONARY ARTERIES. THE PHYSICIAN WAS SUCCESSFUL IN TREATING THE RIGHT ATRIUM A

  Patient problems: Hypovolemia; Low Oxygen Saturation; Tachycardia

  MAUDE report 15465990 ↗