Resolute Integrity™ RSINT25008UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169037342), received between May 29, 2017 and May 29, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2017Material Deformation; Material Deformation

  STENTS WERE PREVIOUSLY IMPLANTED IN THE DISTAL LAD. IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE A RESOLUTE INTEGRITY RX DRUG ELUTING STENT TO TREAT A HEAVILY CALCIFIED AND TORTUOUS MID LAD LESION EXHIBITING 80% STENOSIS. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. NO ISSUES WERE NOTED UPON REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED SUCCESSFULLY. THE LESION WAS PRE-DILATED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHILE ATTEMPTING TO ADVANCE THE STENT BUT NO EXCESSIVE FORCE USED. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED DURING POSITIONING. IT WAS REPORTED THAT THE STENT STRUT WAS FRACTURED. IT WAS REPORTED THAT THE STENT WAS MOST LIKELY DAMAGED WHEN ATTEMPTING TO CROSS STENOSIS. THE ARTERY WAS REPORTED TO BE HEAVILY CALCIFIED. NO PATIENT INJURY REPORTED. PROCEDURE WAS NOT COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6596488 ↗