SET Aspirex™ S 6F 135cm 80325Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07640142811329), received between Oct 10, 2022 and Aug 21, 2026 — classified as 2 deaths, 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2026Material Frayed; Overheating of Device; Mechanical Jam

  On (b)(6) 2026, a patient underwent a thrombectomy and atherectomy procedure using an Aspirex device. During the procedure, it was reported that the catheter became hot to the touch and ceased aspirating thrombotic material. Following removal of the catheter, the device was observed to be frayed. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50365765 ↗
• MalfunctionJan 29, 2025Deformation Due to Compressive Stress; Material Deformation; Deformation Due to Compressive Stress; Material Deformation

  IT WAS REPORTED THAT DURING A THROMBECTOMY AND ATHERECTOMY PROCEDURE, THE CATHETER ALLEGEDLY WAS KINKED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21261470 ↗
• MalfunctionSep 17, 2024Mechanical Jam; Device Handling Problem; Mechanical Jam; Device Handling Problem

  IT WAS REPORTED THAT PRIOR TO A THROMBECTOMY AND ATHERECTOMY PROCEDURE, WHILE FLUSHING THE CATHETER IN A BOWL OF SALINE, THE HELIX SCREW INSIDE THE CATHETER ALLEGEDLY STOPPED SPINNING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20234683 ↗
• MalfunctionApr 11, 2024Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  IT WAS REPORTED THAT PRIOR TO A RECANALIZATION PROCEDURE, UPON OPENING THE PACKAGE, THE SPRING PART OF THE CATHETER WAS ALLEGEDLY FOUND TO BE DAMAGED WHEN ATTEMPTED TO FLUSH THE DEVICE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19085952 ↗
• InjuryJul 5, 2023Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE IN A RADIAL CEPHALIC FISTULA VIA CEPHALIC VEIN RETROGRADE ACCESS, THE UNIT WAS ALLEGEDLY CLUTCHED OUT. IT WAS FURTHER REPORTED THAT WHEN THE DEVICE WAS REMOVED FOR FLUSHING THE UNIT OVER THE WIRE, THE DEVICE ALLEGEDLY THREW THE WIRE UPON FLUSHING. REPORTEDLY, THE WIRE ALLEGEDLY RIPPED THE VEIN AND PERFORATED IT. THE PROCEDURE WAS COMPLETED BY PLACING A PERMCATH. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Perforation of Vessels

  MAUDE report 17254688 ↗
• InjuryMar 23, 2023Break; Break

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE WIRE ALLEGEDLY BROKE INSIDE THE PATIENT. IT WAS FURTHER REPORTED THAT PRIOR TO THE WIRE BREAKING OFF, THE CATHETER WAS ALLEGEDLY CAUGHT ON THE WIRE AFTER MULTIPLE FLUSHES AND WIPE DOWNS OF THE WIRE. REPORTEDLY, THE WIRE BROKE AS THE PHYSICIAN WAS RE-ENTERING THE CATHETER INTO THE SHEATH FOR A FOURTH PASS. HOWEVER, PATIENT HAD A FOGARTY BALLOON THROUGH THE ACCESS AND CHANGED THE PROCEDURE TO AN OPEN THROMBECTOMY. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16601925 ↗
• InjuryFeb 28, 2023Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE FOR THROMBOSED ARTERIOVENOUS GRAFT, THE DEVICE ALLEGEDLY GOT CAUGHT ON TO A VALVE AND TORE THE VEIN OPEN. IT WAS FURTHER REPORTED THAT, THE PATIENT ALLEGEDLY HAD A HOLE IN VESSEL WALL AND EXPERIENCED EXTRAVASATION CAUSED BY THE DEVICE. REPORTEDLY, VEIN RECONSTRUCTION WAS PERFORMED AND SOME COVERED STENTS WERE USED TO HELP COVER THE EXTRAVASATION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THE PATIENT IS STABLE NOW.

  Patient problems: Extravasation; Perforation

  MAUDE report 16451046 ↗
• DeathOct 12, 2022Overheating of Device; Mechanical Jam; Overheating of Device; Mechanical Jam

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE CATHETER AND GUIDEWIRE ALLEGEDLY JAMMED AND OVERHEATED. IT WAS LATER REPORTED THAT WHILE TRANSPORTING THE PATIENT TO THE POST OPERATION AREA, THE PATIENT¿S BP DROPPED AND CRASHED. THE PATIENT REPORTEDLY EXPIRED.

  Patient problems: Insufficient Information

  MAUDE report 15591778 ↗
• DeathOct 12, 2022Overheating of Device; Mechanical Jam; Overheating of Device; Mechanical Jam

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE CATHETER AND GUIDEWIRE ALLEGEDLY JAMMED AND OVERHEATED. IT WAS LATER REPORTED THAT WHILE TRANSPORTING THE PATIENT TO THE POST OPERATION AREA, THE PATIENT¿S BP DROPPED AND CRASHED. THE PATIENT REPORTEDLY EXPIRED.

  Patient problems: Insufficient Information

  MAUDE report 15591663 ↗
• InjuryOct 10, 2022Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING A PROCEDURE VIA CEPHALIC VEIN, THE DEVICE ALLEGEDLY CLUTCHED OUT. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED PERFORATION. REPORTEDLY, PERFORATION WAS TREATED BY PLACING STENTS ON SAME PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Perforation of Vessels

  MAUDE report 15573186 ↗