Integrity INT30022UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994798510), received between Aug 10, 2022 and Aug 10, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2022Use of Device Problem; Material Deformation; Use of Device Problem; Material Deformation

  AN ATTEMPT WAS MADE TO USE A 6F TELESCOPE GUIDE EXTENSION CATHETER AND TWO INTEGRITY RX BARE METAL STENTS TO TREAT A MODERATELY TORTUOUS, NON-CALCIFIED LESION IN THE PROXIMAL SUBCLAVIAN ARTERY. A RADIAL APPROACH WAS USED. THE DEVICES WERE REMOVED FROM THE PACKAGING PER IFU WITH NO ISSUES NOTED. THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. THE DEVICES WERE PREPPED PER IFU WITH NO ISSUES NOTED. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICES. EXCESSIVE FORCE WAS NOT USED. RESISTANCE WAS ENCOUNTERED WHEN USING THE TELESCOPE DEVICE WITH NON-MEDTRONIC GUIDEWIRES. THE TELESCOPE DEVICE WAS NOT EXCESSIVELY TORQUED. THE TELESCOPE DEVICE ENTERED THE VESSEL WITH TWO NON-MEDTRONIC GUIDEWIRES. IT WAS REPORTED THAT WHEN PUSHING THE INTEGRITY STENTS TO THE TARGET LESION THEY BECAME STUCK MIDWAY AND RESISTANCE WAS ENCOUNTERED. THE STENTS WERE STUCK AT THE ENTRY PORT OF THE TELESCOPE. IT WAS ALSO REPORTED THAT THE SECOND GUIDE WIRE BECAME TANGLED WITH THE TELESCOPE DEVICE AT THE PUSH WIRE SECTION BEFORE THE RAMP. AS A RESULT, IT WAS NOT POSSIBLE TO WITHDRAW THE WIRE AND THE WHOLE SYSTEM WAS RETREATED. THERE WERE NO ISSUES NOTED WITH THE FIRST GUIDEWIRE. THE GUIDEWIRES WERE EXAMINED AND FL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15202611 ↗
• MalfunctionAug 10, 2022Use of Device Problem; Material Deformation; Use of Device Problem; Material Deformation

  AN ATTEMPT WAS MADE TO USE A 6F TELESCOPE GUIDE EXTENSION CATHETER AND TWO INTEGRITY RX BARE METAL STENTS TO TREAT A MODERATELY TORTUOUS, NON-CALCIFIED LESION IN THE PROXIMAL SUBCLAVIAN ARTERY. A RADIAL APPROACH WAS USED. THE DEVICES WERE REMOVED FROM THE PACKAGING PER IFU WITH NO ISSUES NOTED. THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. THE DEVICES WERE PREPPED PER IFU WITH NO ISSUES NOTED. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICES. EXCESSIVE FORCE WAS NOT USED. RESISTANCE WAS ENCOUNTERED WHEN USING THE TELESCOPE DEVICE WITH NON-MEDTRONIC GUIDEWIRES. THE TELESCOPE DEVICE WAS NOT EXCESSIVELY TORQUED. THE TELESCOPE DEVICE ENTERED THE VESSEL WITH TWO NON-MEDTRONIC GUIDEWIRES. IT WAS REPORTED THAT WHEN PUSHING THE INTEGRITY STENTS TO THE TARGET LESION THEY BECAME STUCK MIDWAY AND RESISTANCE WAS ENCOUNTERED. THE STENTS WERE STUCK AT THE ENTRY PORT OF THE TELESCOPE. IT WAS ALSO REPORTED THAT THE SECOND GUIDE WIRE BECAME TANGLED WITH THE TELESCOPE DEVICE AT THE PUSH WIRE SECTION BEFORE THE RAMP. AS A RESULT, IT WAS NOT POSSIBLE TO WITHDRAW THE WIRE AND THE WHOLE SYSTEM WAS RETREATED. THERE WERE NO ISSUES NOTED WITH THE FIRST GUIDEWIRE. THE GUIDEWIRES WERE EXAMINED AND FL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15202281 ↗