Resolute Integrity™ RSINT25030UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169037526), received between Jun 12, 2017 and Feb 26, 2019 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (6 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.

• MalfunctionFeb 26, 2019Material Deformation; Material Deformation

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE A RESOLUTE INTEGRITY RX CORONARY DRUG ELUTING STENT TO TREAT A HEAVILY CALCIFIED RCA. IT IS REPORTED THAT THE STENT WOULD NOT CROSS THE LESION AND THE STENT WAS DEFORMED. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8370221 ↗
• MalfunctionFeb 19, 2019Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE INTEGRITY RX CORONARY DRUG ELUTING STENT DURING A PROCEDURE. IT WAS REPORTED THAT THE STENT FAILED TO CROSS THE LESION AND STENT DEFORMATION OCCURRED. IT IS INDICATED THAT THE STENT FAILED TO CROSS THE LESION DUE TO IT EXHIBITING DIFFICULT CALCIFICATION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8350254 ↗
• MalfunctionAug 23, 2018Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE 2 X 2.5X30MM RESOLUTE INTEGRITY DRUG ELUTING STENTS TO TREAT LESIONS IN THE MID TO DISTAL RCA WITH SEVERE CALCIFICATION AND 100% STENOSIS. NO DAMAGED WAS NOTED TO PACKAGING, NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED, THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED, THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED A EUPHORA BALLOON. AN ATTEMPT WAS MADE TO USE A 2.5X12MM RESOLUTE INTEGRITY, BUT IT FAILED TO CROSS THE LESION. THE LESION WAS FURTHER DILATED WITH EUPHORA BALLOON. A 2.5X22MM RESOLUTE INTEGRITY STENT INSERTED, BUT FAILED TO CROSS THE LESION DUE TO CALCIFICATION. THE LESION WAS FURTHER DILATED WITH EUPHORA BALLOON. ONE OF THE 2.5X30MM RESOLUTE INTEGRITY STENTS WAS INSERTED BUT FAILED TO CROSS. A 2.5X 22MM RESOLUTE INTEGRITY STENT WAS INSERTED, BUT FAILED TO CROSS. THE LESION WAS FURTHER DILATED WITH EUPHORA BALLOON. A 2.5X 22MM RESOLUTE INTEGRITY STENT WAS DEPLOYED IN THE DISTAL RCA. THE 2.5X30MM RESOLUTE INTEGRITY STENT WAS REINSERTED, FAILED TO CROSS AND THE END OF STENT WAS DEFORMED UPON INSPECTION, DUE TO EXCESSIVE FORCE APPLIED TO THE STENT TO CROSS THE LESION. THE 2.5X 12MM RESOLUTE INTEGRITY WAS REINSERTE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7808975 ↗
• MalfunctionAug 23, 2018Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE 2 X 2.5X30MM RESOLUTE INTEGRITY DRUG ELUTING STENTS TO TREAT LESIONS IN THE MID TO DISTAL RCA WITH SEVERE CALCIFICATION AND 100% STENOSIS. NO DAMAGED WAS NOTED TO PACKAGING, NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED, THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED, THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED A EUPHORA BALLOON. AN ATTEMPT WAS MADE TO USE A 2.5X12MM RESOLUTE INTEGRITY, BUT IT FAILED TO CROSS THE LESION. THE LESION WAS FURTHER DILATED WITH EUPHORA BALLOON. A 2.5X22MM RESOLUTE INTEGRITY STENT INSERTED, BUT FAILED TO CROSS THE LESION DUE TO CALCIFICATION. THE LESION WAS FURTHER DILATED WITH EUPHORA BALLOON. ONE OF THE 2.5X30MM RESOLUTE INTEGRITY STENTS WAS INSERTED BUT FAILED TO CROSS. A 2.5X 22MM RESOLUTE INTEGRITY STENT WAS INSERTED, BUT FAILED TO CROSS. THE LESION WAS FURTHER DILATED WITH EUPHORA BALLOON. A 2.5X 22MM RESOLUTE INTEGRITY STENT WAS DEPLOYED IN THE DISTAL RCA. THE 2.5X30MM RESOLUTE INTEGRITY STENT WAS REINSERTED, FAILED TO CROSS AND THE END OF STENT WAS DEFORMED UPON INSPECTION, DUE TO EXCESSIVE FORCE APPLIED TO THE STENT TO CROSS THE LESION. THE 2.5X 12MM RESOLUTE INTEGRITY WAS REINSERTED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7808960 ↗
• MalfunctionNov 21, 2017Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE A RESOLUTE INTEGRITY RX CORONARY DRUG ELUTING STENT TO TREAT A MILDLY CALCIFIED AND MILDLY TORTUOUS LESION LOCATED AT THE DISTAL RIGHT CORONARY ARTERY EXHIBITING 95% STENOSIS. ABNORMALITIES WERE REPORTED IN RELATION TO ANATOMY IN THAT A PREVIOUS STENT WAS IMPLANTED. 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 IDENTIFIED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICE DID PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE STENT DEFORMED DURING POSITIONING. IT WAS DESCRIBED THAT THE ANGLE OF THE AL1 GUIDE WAS AN ACUTE ANGLE TO THE VESSEL AND CREATED AN EXTREME ANGLE INTO THE VESSEL. THE STENT INCURRED SOME RESISTANCE UPON CROSSING THAT ANGLE AND THIS POSSIBLY LIFTED OR DAMAGED THE STENT STRUT. THE PHYSICIAN STATED THAT THE STENT DAMAGE WAS NOTED AND THE DEVICE WAS REPLACED WITH A NEW RSINT25030UX WHICH CROSSED SUCCESSFULLY AND THE PROCEDURE WAS COMPLETED. PATIENT STATUS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7047924 ↗
• MalfunctionJun 12, 2017Material Deformation; Material Deformation

  THE PHYSICIAN INTENDED TO USE A RESOLUTE INTEGRITY DRUG ELUTING STENT TO TREAT A LESION LOCATED IN THE (B)(6) BRANCH WHICH WAS REPORTED TO BE MODERATELY TORTUOUS AND SEVERELY CALCIFIED. NO DAMAGE WAS NOTED TO PACKAGING AND NO ISSUES WERE NOTED WHEN REMOVING THE DEVICES FROM THE TRAY. THE DEVICE WAS INSPECTED WITH NO ISSUES IDENTIFIED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT DURING POSITIONING/ADVANCEMENT OF THE STENT, STENT DEFORMATION OCCURRED. THE PHYSICIAN PULLED BACK TO ADJUST THE POSITION AND THE STENT SNAGGED ON A PIECE OF CALCIUM. THE STENT WAS REMOVED AND IT WAS NOTED THAT THERE WAS SOME DEFORMATION OF THE STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND NO EXCESSIVE FORCE WAS USED DURING DELIVERY. THE STENT WAS REPLACED WITH ANOTHER 2.5 X 30 RESOLUTE INTEGRITY DRUG ELUTING STENT. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6632997 ↗