Resolute Integrity™ RSINT30012UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169037496), received between May 15, 2017 and Apr 28, 2021 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2021Burst Container or Vessel; Inflation Problem; Burst Container or Vessel; Inflation Problem

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE INTEGRITY RX CORONARY DRUG ELUTING STENT TO TREAT A NON-CALCIFIED LESION LOCATED IN THE RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. IT WAS REPORTED THAT INFLATION DIFFICULTIES OCCURRED DURING BALLOON INFLATION AND THE BALLOON WOULD NOT COME OFF THE STENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11736279 ↗
• MalfunctionJun 8, 2020Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE INTEGRITY RX CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS AND MILDLY CALCIFIED LESION LOCATED IN THE MID CX ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED.THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT DURING STENT DEPLOYMENT AT 12 ATMS INFLATION DIFFICULTIES WERE ENCOUNTERED ON THE FIRST INFLATION ATTEMPT. IT WAS ALSO REPORTED THAT A LEAK WAS NOTICED IN THE CATHETER WHEN THE STENT BALLOON WOULD NOT INFLATE. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10127161 ↗
• MalfunctionOct 21, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A RESOLUTE INTEGRITY RX CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS, NON CALCIFIED PROXIMAL RIGHT CORONARY ARTERY (RCA). SOME RESISTANCE WAS NOTED WHEN REMOVING THE STYLETTE. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED. THE DEVICE RETURNED WITH A DETACHMENT ON THE HYPOTUBE. AS THE STENT WAS BEING ADVANCED, RESISTANCE WAS FELT, BUT ADVANCEMENT WAS CONTINUED. AT THAT TIME THE CATHETER BROKE. IT WAS REPORTED THAT THE DETACHMENT OCCURRED OUTSIDE OF THE BODY. THEY WERE ABLE TO REMOVE AND USE ANOTHER NEW STENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9212920 ↗
• MalfunctionFeb 8, 2019Use of Device Problem; Use of Device Problem

  A RESOLUTE INTEGRITY DRUG ELUTING STENT WAS INTENDED TO BE USED IN THE PROXIMAL LAD TO TREAT A LESION EXHIBITING MILD TORTUOSITY, MILD CALCIFICATION AND 70% STENOSIS. NO DAMAGE WAS NOTED TO THE PACKAGING. NO ISSUES REMOVING THE DEVICE FROM THE HOOP. DEVICE WAS NOT INSPECTED. THE LESION WAS PRE-DILATED. DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT IS REPORTED THAT THE DEVICE WAS EXPIRED APPROX. 2 AND A HALF MONTHS WHEN IMPLANTED. NO OTHER ISSUES EXPRESSED. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8319417 ↗
• MalfunctionJun 15, 2017Material Deformation; Material Deformation

  THE PHYSICIAN INTENDED TO USE A RESOLUTE INTEGRITY DRUG ELUTING STENT TO TREAT A LESION LOCATED IN THE PROXIMAL DIAGONAL. IT WAS REPORTED THAT THE STENT COULD NOT CROSS THE LESION AND BECAME DEFORMED. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6643008 ↗
• MalfunctionMay 15, 2017Material Deformation; Material Deformation

  THE PHYSICIAN WAS ATTEMPTING TO USE A RESOLUTE INTEGRITY DRUG ELUTING STENT DURING A PROCEDURE TO TREAT A LESION IN A DISTAL RCA. LESION WAS PRE-DILATED TWICE AT 10 ATMS, MAX 30 SECS WITH A EUPHORA BALLOON. THE RESOLUTE INTEGRITY STENT WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT TO THE LESION. IT IS REPORTED THAT THE STENT DEFORMED. THE PHYSICIAN USED 4 ANOTHER RESOLUTE INTEGRITY STENTS TO COMPLETE THE PROCEDURE. THERE IS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6566446 ↗