Resolute Integrity™ RSINT35015UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169037113), received between Dec 15, 2016 and Feb 21, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionFeb 21, 2017Leak/Splash; Leak/Splash

  THE PHYSICIAN WAS ATTEMPTING TO IMPLANT A RESOLUTE INTEGRITY STENT. THE TARGET LESION LOCATED IN THE PROXIMAL LAD WAS REPORTED TO BE MODERATELY TORTUOUS, WITH NO CALCIFICATION AND 100% STENOSIS. PROCEDURE WAS PROMPTED BY STEMI. PRIOR TO THE PROCEDURE, NO DAMAGE WAS NOTED TO PACKAGING AND NO ISSUES WERE REPORTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED AND NEGATIVE PREP WAS CARRIED OUT BOTH WITH NO ISSUES REPORTED. THE LESION WAS PRE-DILATED. DURING ATTEMPTED STENT DEPLOYMENT, THE STENT WAS PLACED ACROSS THE STENOSIS. INFLATION OF THE BALLOON WAS ATTEMPTED AT 4-5ATMS FOR THE FIRST TIME BUT THE BALLOON NEVER INFLATED AT ALL. WHEN PULLING NEGATIVE ON THE STENT DELIVERY SYSTEM, BLOOD CAME BACK INTO THE INFLATION DEVICE. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE DEVICE WAS NOT MOVED OR REPOSITIONED IN THE LESION PRIOR TO THE ISSUE NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER NON-MEDTRONIC STENT AS NO OTHER RESOLUTE INTEGRITY WAS AVAILABLE IN THAT SIZE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6344928 ↗
• MalfunctionDec 15, 2016Material Deformation; Material Deformation

  THE PHYSICIAN INTENDED TO USE A RESOLUTE INTEGRITY 3.5 X 15MM DRUG-ELUTING STENT. IT WAS CONFIRMED THAT THE STENT WAS INSPECTED AND SEEN TO BE NORMAL WHEN REMOVED FROM ORIGINAL PACKAGING. IT IS REPORTED THAT, FOLLOWING MANY PRE-DILATIONS, THE STENT WAS NOTED TO BE DEFORMED, AFTER PUSHING, DURING ATTEMPTED DELIVERY IN A HEAVILY CALCIFIED CTO VESSEL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6176509 ↗