Integrity INT22512UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994798695), received between Dec 2, 2016 and Mar 8, 2017 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

• InjuryMar 8, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE AN INTEGRITY BARE METAL STENT TO TREAT A LESION IN THE LAD WITH NO TORTUOSITY, SEVERE CORONARY ARTERY DISEASE WAS NOTED. NO ISSUES REMOVING THE PROTECTIVE SHEATH. DEVICE WAS INSPECTED BEFORE USE, NO ISSUES NOTED. LESION WAS PRE-DILATED WITH A 2.25 BALLOON. INFLATION DEVICE REMAINED ON NEUTRAL PRESSURE DURING DELIVERY OF THE DEVICE. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT THE STENT DISLODGED IN THE PATIENT DURING WITHDRAWAL OF THE DEVICE IN THE VESSEL/GUIDE CATHETER. IT IS REPORTED THAT THE STENT WAS UNABLE TO CROSS SO GUIDE LINER AND STENT WERE REMOVED FROM PATIENT. AT THAT POINT IT WAS NOTED THE STENT WAS NOT ON THE BALLOON. AFTER USING IVUS, THE STENT WAS SEEN AT THE CRUX OF CIRCUMFLEX AND LAD, CAUGHT BY PREVIOUS PLACED STENT, FROM ANOTHER DATE. THE DISLODGED STENT WAS JAILED AGAINST THE WALL WITH A BALLOON. CASE WAS THEN STOPPED. STENT WAS NOT REMOVED FROM THE PATIENT.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6386697 ↗
• InjuryDec 2, 2016Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO TREAT 90% OSTIAL RIGHT CORONARY ARTERY STENOSIS AND AN 80% MID RIGHT CORONARY ARTERY STENOSIS AND HEAVILY CALCIFIED AND TORTUOUS RIGHT CORONARY ARTERY. THE PHYSICIAN SELECTED AN INTEGRITY 2.25X12MM STENT. NO DAMAGE NOTED TO DEVICE PACKAGING OR ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. DURING THE PROCEDURE, THE LESION WAS PRE-DILATED PRIOR TO ATTEMPT TO IMPLANT STENT. IT WAS REPORTED THAT THE STENT DISLODGED DURING REMOVAL FOLLOWING FAILED DELIVERY AND WAS RETRIEVED BY SNARE. IT WAS REPORTED THAT THE PHYSICIAN SELECTED ANOTHER INTEGRITY 2.25X14MM STENT TO CONTINUE THE PROCEDURE. NO DAMAGE NOTED TO DEVICE PACKAGING. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT THE STENT FELL OFF IN THE AORTA AND AN ATTEMPT WAS MADE TO SNARE THE STENT BUT WAS UNSUCCESSFUL.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6140596 ↗