Resolute Integrity™ RSINT35030UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169037274), received between Dec 19, 2016 and May 11, 2017 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Expiration Issue” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2017Device Expiration Issue; Device Expiration Issue

  IT WAS REPORTED THAT A RESOLUTE INTEGRITY RX DRUG ELUTING STENT WAS IMPLANTED IN A PATIENT TO TREAT IN-STENT RE-STENOSIS OF A NON-MDT STENT. (EVEROLIMUS) THE RESOLUTE INTEGRITY STENT WAS IMPLANTED 18 DAYS POST ITS EXPIRY DATE. NO PATIENT INJURY REPORTED. PATIENT IS CURRENTLY OK

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6559630 ↗
• MalfunctionMar 28, 2017Device Expiration Issue; Device Expiration Issue

  IT IS REPORTED THAT A RESOLUTE INTEGRITY DRUG ELUTING STENT WAS USED IN THE PATIENT 8 DAYS POST EXPIRATION DATE. NO PATIENT INJURY REPORTED FOR THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6438649 ↗
• MalfunctionDec 19, 2016Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PHYSICIAN IMPLANTED A RESOLUTE INTEGRITY RX DRUG ELUTING STENT. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO EXCESSIVE FORCE WAS USED DURING DEVICE DELIVERY. THE STENT WAS EXPANDED EVENLY ALONG THE ENTIRE LENGTH. SUFFICIENT TIME WAS GIVEN TO ALLOW THE BALLOON TO FULLY DEFLATE PRIOR TO ATTEMPTING TO REMOVE. IT WAS REPORTED THAT AFTER STENT WAS DEPLOYED RESISTANCE WAS ENCOUNTERED REMOVING THE BALLOON FROM THE STENT . THE BALLOON SEEMED STUCK AND IT WAS REPORTED THAT FORCE WAS REQUIRED TO REMOVE IT. NO DAMAGE TO THE DEPLOYED STENT AND NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6185364 ↗