SET Aspirex™ S 8F 85cm 80326Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07640142811336), received between Feb 29, 2024 and Jan 23, 2026 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2026Break; Detachment of Device or Device Component

  ON (B)(6) 2025, A PATIENT UNDERWENT THROMBECTOMY AND ATHERECTOMY PROCEDURE USING A ASPIREX DEVICE. REPORTEDLY, THE CATHETER SEPARATED FROM THE BUB, EXPOSING THE HELIX AT THE BACK OF THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24158756 ↗
• MalfunctionJun 23, 2025Retraction Problem; Mechanical Jam; Retraction Problem; Mechanical Jam

  ON (B)(6) 2025, A PATIENT UNDERWENT A THROMBECTOMY AND ATHERECTOMY PROCEDURE USING AN 8FR ASPIREX CATHETER. DURING THE PROCEDURE, THE CATHETER ALLEGEDLY BECAME STUCK ON THE WIRE AND COULD NOT BE REMOVED. THEY HAD TO PULL THE ENTIRE DEVICE AND WIRE OUT OF THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22307631 ↗
• MalfunctionMay 23, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ON (B)(6) 2025, A PATIENT UNDERWENT A THROMBECTOMY AND ATHERECTOMY PROCEDURE VIA LEFT LOWER ARM USING ASPIREX. DURING THE PROCEDURE, THE HAND SWITCH ALLEGEDLY CAME APART AND THE BREAKAGE OCCUR OUTSIDE OF THE PATIENT BODY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22080586 ↗
• InjuryDec 27, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A THROMBECTOMY AND ATHERECTOMY PROCEDURE, THE WIRE ALLEGEDLY BROKE IN HALF. IT WAS FURTHER REPORTED THAT THE SNARING THE WIRE OUT NEEDED THREE ACCESSES. THE STATUS OF THE PATIENT UNKNOWN.

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

  MAUDE report 21025793 ↗
• MalfunctionAug 11, 2024Leak/Splash; Mechanical Jam; Leak/Splash; Mechanical Jam

  IT WAS REPORTED THAT DURING A THROMBECTOMY AND ATHERECTOMY PROCEDURE IN THE RIGHT FEMORAL VEIN VIA THE RIGHT POPLITEAL VEIN, THE CATHETER ALLEGEDLY LEAKED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19958011 ↗
• MalfunctionJun 12, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A THROMBECTOMY AND ATHERECTOMY PROCEDURE, THE TIP OF THE DEVICE ALLEGEDLY BROKE OFF INSIDE THE CEPHALIC VEIN OF THE FISTULA. IT WAS FURTHER REPORTED THAT THE BROKEN PIECE WAS ALLEGEDLY RETRIEVED USING A SNARE DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19516947 ↗
• InjuryMay 7, 2024Leak/Splash; Mechanical Jam; Leak/Splash; Mechanical Jam

  IT WAS REPORTED THAT DURING A THROMBECTOMY AND ATHERECTOMY PROCEDURE IN THE LEFT UPPER ARM CLOTTED FISTULA VIA THE UPPER ARM CEPHALIC VEIN APPROACH, THE SYSTEM ALLEGEDLY CLUTCHED OUT AND MADE A LOUD NOISE WHILE BEGAN TO WORK. IT WAS FURTHER REPORTED THAT WHEN THE CATHETER WAS REMOVED AND FLUSHED, A FIBROUS PIECE OF TISSUE WAS ALLEGEDLY FOUND TO BE ADHERED TO THE TIP OF THE CATHETER. FURTHERMORE, THE CATHETER WAS PASSED AGAIN FOR A FEW TIMES THROUGH THE FISTULA, AND IT WAS FOUND THAT THE UPPER ARM CEPHALIC VEIN WAS ALLEGEDLY TORN. REPORTEDLY, A COVERED STENT GRAFT WAS PLACED TO SEAL THE TEAR AND COVER THE LEAK IN THE VEIN. THE PATIENT¿S ACCESS WAS SAVED AND WAS REPORTED TO BE STABLE NOW.

  Patient problems: Perforation of Vessels

  MAUDE report 19256803 ↗
• MalfunctionApr 8, 2024Break; Break

  IT WAS REPORTED THAT DURING A THROMBECTOMY AND ATHERECTOMY PROCEDURE IN THE LEFT ARM ARTERIOVENOUS FISTULA, THE TIP OF THE WIRE ALLEGEDLY SHEARED BUT IT REMAINED INTACT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19057274 ↗
• MalfunctionFeb 29, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PRIOR TO A RECANALIZATION PROCEDURE, THE LABEL OF THE DEVICE WAS ALLEGEDLY FOUND TO BE MISLABELED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18805493 ↗