Resolute Integrity™ RSINT27522UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169037458), received between Aug 13, 2018 and Aug 13, 2018 — classified as 1 injury.

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

• InjuryAug 13, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE RESOLUTE INTEGRITY RX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS AND NONE CALCIFIED LESION LOCATED ON THE PROXIMAL LAD ARTERY EXHIBITING 99% STENOSIS. THERE WERE NO ABNORMALITIES IN RELATION TO THE ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION. THE DISLODGED STENT MIGRATED TO THE DIAGONAL BRANCH AND WAS CRUSHED AGAINST THE VESSEL WALL USING A SIMILAR SIZED STENT. THE PROCEDURE WAS COMPLETED USING A THIRD STENT PRIOR TO CRUSHING THE DISLODGED STENT. PATIENT STATUS POST-PROCEDURE IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient; Patient Problem/Medical Problem

  MAUDE report 7777078 ↗