Resolute Integrity™ RSINT30009UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169037489), received between Apr 5, 2017 and May 8, 2018 — 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.

• InjuryMay 8, 2018Device Damaged by Another Device; Device Dislodged or Dislocated; Device Damaged by Another Device; Device Dislodged or Dislocated

  DURING THE PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE INTEGRITY RX CORONARY DRUG ELUTING STENT TO TREAT A SEVERELY CALCIFIED AND MILDLY TORTUOUS LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY, EXHIBITING 95% STENOSIS. THERE WERE NO ABNORMALITIES IN RELATION TO 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. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. A RIGHT RADIAL APPROACH WAS USED. THE LESION WAS PRE-DILATED. THE DEVICE PASSED THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT DURING THE DELIVERY OF THE STENT TO THE MID LAD, THE DELIVERY CATHETER BROKE JUST DISTAL TO THE LUER/HUB. THE STENT WAS NOT DEPLOYED, AND THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT ISSUE. AN ATTEMPT WAS MADE TO USE ANOTHER RESOLUTE INTEGRITY RX CORONARY DRUG ELUTING STENT TO TREAT THE SAME LESION. NO DAMAGE WAS NOTED TO PACKAGING. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION PRE-DILATE

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7493627 ↗
• InjuryApr 5, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PHYSICIAN INTENDED TO USE A RESOLUTE INTEGRITY DRUG-ELUTING STENT TO TREAT A CALCIFIED LESION IN THE RCA WITH A PREVIOUS DEPLOYED DES. NO DAMAGE NOTED TO DEVICE PACKAGING. DEVICE WAS INSPECTED PRIOR TO USE NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED FOLLOWED BY NEUTRAL PREP. LESION WAS PRE-DILATED. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE PAST A JUST DEPLOYED RESOLUTE, EXCESSIVE FORCE WAS NOT USED. PHYSICIAN WAS UNABLE TO DEPLOY THE STENT AND WHEN THE PHYSICIAN PULLED IT BACK INTO THE 6F GUIDELINER, HE NOTICED UNDER FLUORO, THAT THE STENT SLIPPED OFF THE BALLOON. HE THEN REMOVED THE GUIDELINER AND THE STENT WITHOUT ANY ISSUE TO THE PATIENT. HE SUCCESSFULLY DEPLOYED A RESOLUTE IMMEDIATELY AFTERWARDS. PHYSICIAN INSISTS THAT THERE WAS NO ISSUE WITH THE RESOLUTE INTEGRITY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6459553 ↗