SET Aspirex™ S 8F 110cm 80327Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07640142811343), received between Sep 16, 2022 and Sep 17, 2024 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2024Break; Break

  IT WAS REPORTED THAT DURING THROMBECTOMY AND ATHERECTOMY PROCEDURE, THE DEVICE ALLEGEDLY UNTHREADED THE WIRE WHICH GOT STUCK IN THE PATIENT. IT WAS FURTHER THAT THE TRI LOOP SNARE WAS ALLEGEDLY USED TO RETRIEVE THE WIRE FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20234872 ↗
• MalfunctionApr 6, 2023Break; Retraction Problem; Break; Retraction Problem

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, UPON THE START OF OPERATION IN THE BODY THE CATHETER ALLEGEDLY WOULD NOT MOVE BACK ON THE WIRE. IT WAS FURTHER REPORTED THAT UPON FLUOROSCOPIC EXAMINATION IT WAS OBSERVED THAT THERE WAS A WELL OVER TEN CENTIMETERS OF WIRE PROTRUDED OUT OF THE TIP OF THE CATHETER. FURTHERMORE, THE PHYSICIAN ATTEMPTED TO REMOVE THE CATHETER OVER THE WIRE AND OUT THE SHEATH, AND IT DID NOT MOVE. REPORTEDLY AFTER MULTIPLE ATTEMPTS TO REMOVE THE CATHETER OVER THE WIRE FAILED AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16690691 ↗
• InjuryApr 4, 2023Break; Break

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE DEVICE ALLEGEDLY HAD A BREAK BEHIND THE HEMOSTATIC VALVE. IT WAS FURTHER REPORTED THAT THERE WAS BREAK ON THE FRONT WIRE WHILE THE CATHETER WAS PULLED OUT. REPORTEDLY THREE PIECES BROKE OFF AND ONE WAS RETRIEVED USING SNARE AND THE OTHER WAS UNABLE TO BE RETRIEVED AND ONE PIECE OF THE WIRE WAS LEFT IN THE TRIBUTARY OF THE ARM. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 16676195 ↗
• MalfunctionNov 25, 2022Break; Break

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE CATHETER OF THE DEVICE ALLEGEDLY FRACTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15864583 ↗
• InjuryOct 18, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE GUIDEWIRE ALLEGEDLY STUCK INSIDE THE PATIENT. THE DOCTOR ATTEMPTED TO USE A SNARE RETRIEVAL KIT TO RETRIEVE THE WIRE BUT WAS UNSUCCESSFUL DUE TO ITS PLACEMENT AND THE ANGLE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 15623433 ↗
• InjuryOct 12, 2022Break; Break

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE GUIDEWIRE ALLEGEDLY BROKEN. IT WAS FURTHER REPORTED THAT CUTDOWN IN THE PATIENT¿S UPPER ARM WAS DONE TO RETRIEVE THE BROKEN WIRE AND THEN TO COMPLETE THE THROMBECTOMY. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 15585163 ↗
• MalfunctionSep 28, 2022Break; Mechanical Jam; Physical Resistance/Sticking; Break; Mechanical Jam; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A PROCEDURE, THE CATHETER ALLEGEDLY STOPPED WORKING. IT WAS FURTHER REPORTED THAT THE GUIDEWIRE WAS ALLEGEDLY STUCK WITH THE CATHETER AND WAS REMOVED AS A UNIT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15499768 ↗
• MalfunctionSep 16, 2022Mechanical Jam; Physical Resistance/Sticking; Mechanical Jam; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE CATHETER ALLEGEDLY STOPPED WORKING. IT WAS FURTHER REPORTED THAT THE GUIDEWIRE WAS ALLEGEDLY STUCK WITH THE CATHETER AND WAS REMOVED AS A UNIT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15439844 ↗