Triever20 21-101 (UDI 00810123710065)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810123710065), received between Mar 4, 2025 and Jul 1, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2025Retraction Problem; Material Separation; Retraction Problem; Material Separation

  ON (B)(6) 2025, A PATIENT UNDERWENT DEEP VEIN THROMBOSIS (DVT) THROMBECTOMY USING INARI DEVICES. THE PATIENT'S CLOT AGE WAS ESTIMATED AT 14 DAYS. WHEN ATTEMPTING TO REMOVE THE TRIEVER 20 AFTER THE FINAL ASPIRATION, THE CATHETER BECAME STUCK IN THE PATIENT'S VESSEL. FOLLOWING MULTIPLE ATTEMPTS TO REMOVE THE DEVICE USING BALLOONING AND MEDICATION, THE DEVICE SEPARATED AND APPROXIMATELY 10-15CM OF THE CATHETER REMAINED IN THE PATIENT. THE MEDICAL TEAM WAS UNSUCCESSFUL IN REMOVING THE REMAINING PART OF THE CATHETER DURING THE PROCEDURE, HOWEVER; THE MEDICAL TEAM WAS ABLE TO REMOVE THE PIECE OF THE DEVICE THE FOLLOWING DAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 22375105 ↗
• MalfunctionMar 4, 2025Entrapment of Device; Difficult to Remove; Material Separation; Entrapment of Device; Difficult to Remove; Material Separation

  ON (B)(6) 2025, A 49-YEAR-OLD MALE UNDERWENT DEEP VEIN THROMBOSIS (DVT) THROMBECTOMY USING INARI DEVICES. THE PATIENT'S CLOT AGE WAS ESTIMATED AT 90 DAYS. DURING THE THROMBECTOMY, THE TREIVER20 CATHETER (T20) WAS ADVANCED WITHOUT AN INTRODUCER SHEATH INTO THE LEFT POPLITEAL VEIN. AN ASPIRATION WAS PERFORMED, AND THE CATHETER WAS RETRACTED. THE TIP OF THE CATHETER BECAME STUCK WHILE RETRACTING THE CATHETER THROUGH THE COMMON ILIAC VEIN. THE CATHETER WAS RETRACTED A FEW MORE INCHES AND THEN FRACTURED. HALF OF THE CATHETER AND THE DILATOR WERE REMOVED AND APPROXIMATELY 20 CENTIMETERS OF THE T20 DELIVERY CATHETER REMAINED IN THE PATIENT'S VESSEL. SCISSORS WERE USED TO CUT THE WIRE BRAIDING OF THE T20. AN INTRI24 INTRODUCER SHEATH (INTRI24) WAS THEN ADVANCED TO WHERE THE TIP WAS JUST OVER THE PROXIMAL (BROKEN) END OF THE T20 AND A 10X40 BALLOON WAS PLACED OVER THE WIRE AT THE DISTAL END OF THE REMAINING PORTION OF THE T20 CATHETER INTO THE INTRI24. THE INTRI24, T20 CATHETER, AND BALLOON WERE THEN REMOVED TOGETHER AND THE INTRI24 WAS FLUSHED AND REPLACED INTO THE LEFT POPLITEAL VEIN. ALL MATERIAL WAS CONFIRMED TO BE REMOVED FROM THE PATIENT AND THE PATIENT SUSTAINED NO INJURIES. THE PATI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21520940 ↗