Aspirex® S 8F 110cm 80204Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07640142810483), received between Feb 28, 2023 and Sep 9, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT THROMBECTOMY AND ATHERECTOMY PROCEDURE USING A ASPIREX DEVICE. DURING THE PROCEDURE, IT WAS NOTED THAT THE REFERENCE CATALOGUE NUMBER AND LOT/BATCH NUMBERS ON THE CATHETER INNER PACKAGE AND THE OUTER PACKAGE WERE NOT IDENTICAL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23000890 ↗
• MalfunctionSep 9, 2025Break; Deformation Due to Compressive Stress; Device Markings/Labelling Problem; Mechanical Jam; Break; Deformation Due to Compressive Stress; Device Markings/Labelling Problem; Mechanical Jam

  ON (B)(6) 2025, A PATIENT UNDERWENT THROMBECTOMY AND ATHERECTOMY PROCEDURE USING A ASPIREX DEVICE. DURING THE PROCEDURE, ALLEGEDLY THE DEVICE PRODUCED UNUSUAL NOISE. SUBSEQUENT INSPECTION REVEALED THAT THE OUTER COIL COVERING OF THE CATHETER SHAFT WAS STRIPPED AND DAMAGED AT THAT SPECIFIC LOCATION. REPORTEDLY, AFTER THE MALFUNCTION OCCURRED, THE CATHETER CONTINUED TO ROTATE MECHANICALLY, BUT NO ASPIRATION WAS ACHIEVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ARGON CLEANER + CQF TO REMOVE THE THROMBUS. ALSO, IT WAS FURTHER REPORTED THAT THE REF AND LOT NUMBERS ON THE CATHETER PACKAGE AND THE OUTER BOX WERE NOT IDENTICAL. THERE IS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23000865 ↗
• MalfunctionFeb 28, 2023Retraction Problem; Mechanical Jam; Retraction Problem; Mechanical Jam

  IT WAS REPORTED THAT DURING RECANALIZATION PROCEDURE VIA POPLITEAL ACCESS FOR A PATIENT DIAGNOSED WITH DEEP VEIN THROMBOSIS, THE DEVICE WIRE ALLEGEDLY COULD NOT BE REMOVED FROM THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16451560 ↗