SET Aspirex™ S 10F 110cm 80328Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07640142811350), received between Aug 8, 2022 and Dec 17, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 17, 2025Mechanical Jam; Mechanical Jam

  ON (B)(6) 2025, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING THE ASPIREX CATHETER. DURING PROCEDURE, IT WAS REPORTED THAT THE GUIDEWIRE WAS CAUGHT INSIDE THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23829840 ↗
• MalfunctionJun 9, 2025Leak/Splash; Mechanical Jam; Leak/Splash; Mechanical Jam

  ON (B)(6) 2025, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING THE ASPIREX CATHETER. DURING THE PROCEDURE IN THE POPLITEAL VEIN VIA IPSILATERAL APPROACH, THE LARGE AMOUNT OF BLOOD COMING OUT THE BACK OF THE GREEN HANDLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22165268 ↗
• MalfunctionSep 16, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PREPARATION FOR A THROMBECTOMY AND ATHERECTOMY PROCEDURE, WHILE SUBMERGING THE CATHETER IN THE BOWL OF SALINE TO PREPARE, THE CATHETER ALLEGEDLY CUT THE WIRE INTO TWO PIECES. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20223039 ↗
• MalfunctionAug 22, 2024Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT DURING A THROMBECTOMY AND ATHERECTOMY PROCEDURE IN THE EXTERNAL ILIAC VEIN LESION VIA THE COMMON FEMORAL VEIN IPSILATERAL APPROACH, THE DEVICE ALLEGEDLY DID NOT CLUTCH OUT IN THE LESION. IT WAS FURTHER REPORTED THAT THE HELIX OF THE CATHETER ALLEGEDLY BROKE. REPORTEDLY, THE DEVICE WAS TAKEN OUT FROM 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 20034644 ↗
• MalfunctionMar 6, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE IN THE COMMON FEMORAL VEIN AND EXTERNAL ILIAC VEIN VIA THE POPLITEAL VEIN ACCESS, THE TIP OF THE GUIDEWIRE WAS ALLEGEDLY BROKEN OFF INSIDE THE PATIENT'S HEART. IT WAS FURTHER REPORTED THAT THE RETAINED MARKER PORTION OF THE WIRE WAS RETRIEVED WITH A SNARE DEVICE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18844195 ↗
• MalfunctionJun 20, 2023Break; Device Handling Problem; Break; Device Handling Problem

  IT WAS REPORTED THAT PRIOR TO RECANALIZATION PROCEDURE, THE CATHETER SPRING ALLEGEDLY BROKE UPON OPENING. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

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

  MAUDE report 17167163 ↗
• MalfunctionMay 16, 2023Break; Break

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE VIA LEFT POPLITEAL VEIN, THE GOLD PART OF THE TIP OF THE WIRE WAS ALLEGEDLY SHEERED OFF IN THE PATIENT. IT WAS FURTHER REPORTED THAT WHEN THE WIRE WAS REMOVED, THERE WAS A PIECE OF THE WIRE STILL IN THE PATIENT. REPORTEDLY, SNARE WAS USED TO REMOVE THE SHEARED WIRE THAT WAS LEFT IN THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16937774 ↗
• MalfunctionMar 29, 2023Mechanical Jam; Physical Resistance/Sticking; Mechanical Jam; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE IN THE ILIOFEMORAL VEIN VIA POPLITEAL VEIN ACCESS, THE WIRE WAS ALLEGEDLY STUCK TO THE INTERNAL HELIX OF THE DEVICE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16634716 ↗
• MalfunctionNov 16, 2022Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15803820 ↗
• MalfunctionNov 4, 2022Break; Overheating of Device; Break; Overheating of Device

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE IN THE ILIAC VEIN VIA THE LEFT POPLITEAL ARTERY, THE CATHETER ALLEGEDLY HAD OVERHEATED. IT WAS FURTHER REPORTED THAT THE CATHETER ALLEGEDLY BROKE WHILE IN THE PATIENT. REPORTEDLY, CATHETER WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15730962 ↗
• MalfunctionSep 20, 2022Break; Break

  IT WAS REPORTED THAT DURING PREPARATION FOR A RECANALIZATION PROCEDURE VIA THE COMMON FEMORAL VEIN, THE HELIX SCREW THAT WAS INSIDE THE CATHETER ALLEGEDLY BROKE FROM THE HANDLE OF THE CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15453797 ↗
• MalfunctionAug 8, 2022Break; Break

  IT WAS REPORTED THAT PRIOR TO A RECANALIZATION PROCEDURE, THE HELIX ALLEGEDLY BROKEN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15181109 ↗