Resolute Integrity™ RSINT35022UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169037137), received between Jun 21, 2017 and Nov 23, 2021 — classified as 2 injuries, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TWO RESOLUTE INTEGRITY CORONARY DRUG ELUTING STENTS WERE IMPLANTED IN A PATIENT. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN ALLERGIC REACTION WITH RED SKIN THROUGH WHOLE BODY. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Local Reaction

  MAUDE report 12861235 ↗
• MalfunctionJun 13, 2019Material Deformation; Material Deformation

  IT WAS INDICATED ON A NON COMPLAINT PRODUCT REPLACEMENT FORM THAT A RESOLUTE INTEGRITY RX CORONARY, DRUG ELUTING STENT WAS UNABLE TO CROSS AND WHEN REMOVED HAD DAMAGED STRUTS. THE LESION WAS PRE-DILATED. IT WAS A CALCIFIED AND TORTUOUS MID RCA. NO PATIENT INJURY IS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8694924 ↗
• InjuryJun 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD TWO RESOLUTE INTEGRITY STENTS IMPLANTED DURING THE INDEX PROCEDURE. THREE DAYS POST PROCEDURE, THE PATIENT BEGAN EXPERIENCING SYMPTOMS INCLUDING A RASH ON THE LEG AND THEN A SCAB ON THE FOOT. THE PATIENT HAS EXPERIENCED CONSTANT ITCH TERRIBLY SINCE THEN. IT WAS REPORTED THAT THE PATIENT ALSO DEVELOPED CELLULITIS AND HAS BEEN HOSPITALIZED BECAUSE OF THE RASH AND ON PREDNISONE EVER SINCE. IT IS BELIEVED THAT THE RASH IS RELATED TO THE STENT IMPLANTATION. PATIENT IS STILL BEING TESTED BUT THE SYMPTOMS ARE REDUCING OR BEING BETTER MANAGED.

  Patient problems: Reaction

  MAUDE report 6656122 ↗