Resolute IntegrityRecalls & reported problems across all models
Medtronic, Inc. · 52 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 185
- Deaths reported
- 13
- Injuries reported
- 47
- Recalls
- 0
We found 52 models of Resolute Integrity by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 185 adverse event reports in the FDA's MAUDE database, received between Dec 5, 2016 and Jun 1, 2022 — classified as 13 deaths, 47 injuries, 125 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (83 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Most reported Resolute Integrity problems
Device problems
- Material Deformation83
- Device Dislodged or Dislocated43
- Adverse Event Without Identified Device or Use Problem28
- Detachment of Device or Device Component9
- Leak/Splash8
- Difficult to Remove7
- Inflation Problem7
- Device Expiration Issue4
Patient problems
- No Consequences Or Impact To Patient119
- Patient Problem/Medical Problem26
- Death13
- Reaction8
- Myocardial Infarction5
- No Clinical Signs, Symptoms or Conditions5
- Intimal Dissection4
- Thrombus4
Resolute Integrity models
52 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Resolute Integrity™ RSINT25018UXCoronary drug-eluting stent2 deaths15 reports
- Resolute Integrity™ RSINT30015UXCoronary drug-eluting stent3 deaths13 reports
- Resolute Integrity™ RSINT25022UXCoronary drug-eluting stent1 death10 reports
- Resolute Integrity™ RSINT30022UXCoronary drug-eluting stent1 death9 reports
- Resolute Integrity™ RSINT22514UXCoronary drug-eluting stent9 reports
- Resolute Integrity™ RSINT22512UXCoronary drug-eluting stent1 death8 reports
- Resolute Integrity™ RSINT30018UXCoronary drug-eluting stent7 reports
- Resolute Integrity™ RSINT30038UXCoronary drug-eluting stent7 reports
- Resolute Integrity™ RSINT22518UXCoronary drug-eluting stent7 reports
- Resolute Integrity™ RSINT30026UXCoronary drug-eluting stent6 reports
- Resolute Integrity™ RSINT22530UXCoronary drug-eluting stent6 reports
- Resolute Integrity™ RSINT22522UXCoronary drug-eluting stent1 death6 reports
- Resolute Integrity™ RSINT30012UXCoronary drug-eluting stent6 reports
- Resolute Integrity™ RSINT25030UXCoronary drug-eluting stent6 reports
- Resolute Integrity™ RSINT25014UXCoronary drug-eluting stent4 reports
- Resolute Integrity™ RSINT35012UXCoronary drug-eluting stent3 reports
- Resolute Integrity™ RSINT35018UXCoronary drug-eluting stent3 reports
- Resolute Integrity™ RSINT35022UXCoronary drug-eluting stent3 reports
- Resolute Integrity™ RSINT35026UXCoronary drug-eluting stent3 reports
- Resolute Integrity™ RSINT30030UXCoronary drug-eluting stent3 reports
- Resolute Integrity™ RSINT40022UXCoronary drug-eluting stent3 reports
- Resolute Integrity™ RSINT35030UXCoronary drug-eluting stent3 reports
- Resolute Integrity™ RSINT40012UXCoronary drug-eluting stent1 death3 reports
- Resolute Integrity™ RSINT22526UXCoronary drug-eluting stent3 reports
- Resolute Integrity™ RSINT25026UXCoronary drug-eluting stent3 reports
- Resolute Integrity™ RSINT35009UXCoronary drug-eluting stent2 reports
- Resolute Integrity™ RSINT35015UXCoronary drug-eluting stent2 reports
- Resolute Integrity™ RSINT40030UXCoronary drug-eluting stent2 reports
- Resolute Integrity™ RSINT40038UXCoronary drug-eluting stent2 reports
- Resolute Integrity™ RSINT35038UXCoronary drug-eluting stent2 reports
- Resolute Integrity™ RSINT40009UXCoronary drug-eluting stent1 death2 reports
- Resolute Integrity™ RSINT22508UXCoronary drug-eluting stent1 death2 reports
- Resolute Integrity™ RSINT27526UXCoronary drug-eluting stent2 reports
- Resolute Integrity™ RSINT30009UXCoronary drug-eluting stent2 reports
- Resolute Integrity™ RSINT22514WCoronary drug-eluting stent1 report
- Resolute Integrity™ RSINT25030WCoronary drug-eluting stent1 report
- Resolute Integrity™ RSINT25014WCoronary drug-eluting stent1 report
- Resolute Integrity™ RSINT22518WCoronary drug-eluting stent1 report
- Resolute Integrity™ RSINT30018WCoronary drug-eluting stent1 report
- Resolute Integrity™ RSINT30015WCoronary drug-eluting stent1 report
- Resolute Integrity™ RSINT27512WCoronary drug-eluting stent1 report
- Resolute Integrity™ RSINT30034UXCoronary drug-eluting stent1 report
- Resolute Integrity™ RSINT40018UXCoronary drug-eluting stent1 report
- Resolute Integrity™ RSINT40026UXCoronary drug-eluting stent1 report
- Resolute Integrity™ RSINT35034UXCoronary drug-eluting stent1 report
- Resolute Integrity™ RSINT25008UXCoronary drug-eluting stent1 report
- Resolute Integrity™ RSINT25012UXCoronary drug-eluting stent1 report
- Resolute Integrity™ RSINT27522UXCoronary drug-eluting stent1 report
- Resolute Integrity™ RSINT27530UXCoronary drug-eluting stent1 death1 report
- Resolute Integrity™ RSINT27508UXCoronary drug-eluting stent1 report
- Resolute Integrity™ RSINT27512UXCoronary drug-eluting stent1 report
- Resolute Integrity™ RSINT27518UXCoronary drug-eluting stent1 report
Recent Resolute Integrity adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJun 1, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
ONE RESOLUTE INTEGRITY CORONARY DRUG ELUTING STENT WAS ATTEMPTED TO BE USED TO TREAT A MILDLY TORTUOUS, MODERATELY CALCIFIED LESION IN THE OSTIUM OF THE RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL OF THE DEVICE FOLLOWING A FAILED DELIVERY. AN ATTEMPT WAS MADE TO SNARE THE DISLODGED STENT BUT WAS NOT SUCCESSFUL. THE DISLODGED STENT WAS NOT REMOVED FROM THE PATIENT. IT WAS STATED THAT PCI WAS PERFORMED. NO FURTHER PATIENT INJURY REPORTED.
Patient problems: Insufficient Information
MAUDE report 14562791 ↗InjuryFeb 3, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
ONE RESOLUTE INTEGRITY CORONARY DRUG ELUTING STENT WAS ATTEMPTED TO BE USED TO TREAT A MILDLY TORTUOUS, NON-CALCIFIED LESION IN THE DISTAL INFRA-POPLITEAL ARTERY. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED. THE DEVICE WAS NOT KINKED AND RE-STRAIGHTENED DURING USE. IT WAS REPORTED THAT A DETACHMENT OCCURRED AT THE CATHETER, DURING DELIVERY OF THE DEVICE THROUGH THE VESSEL. NO PATIENT INJURY REPORTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 13440954 ↗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 12861287 ↗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 ↗MalfunctionSep 7, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS INTENDED TO USE A RESOLUTE INTEGRITY CORONARY DRUG ELUTING STENT TO TREAT A CALCIFIED LESION IN THE MID LAD. IT WAS REPORTED THAT THE STENT CAME OFF FROM THE BALLOON INSIDE A NON-MDT GUIDE EXTENSION CATHETER. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12432948 ↗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 ↗InjuryDec 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DURING THE INDEX PROCEDURE ONE RESOLUTE ONYX DES WAS IMPLANTED IN THE LAD. APPROXIMATELY TWO WEEKS LATER DURING A STAGED PROCEDURE, ANGIOGRAPHY AND REVASCULARIZATION WERE PERFORMED AND A RESOLUTE INTEGRITY DES WAS IMPLANTED IN THE RCA. CEC ADJUDICATED THAT NON-TARGET VESSEL MI AND SIDE BRANCH OCCLUSION OF THE RCA OCCURRED POST STAGED PROCEDURE.
Patient problems: Myocardial Infarction; Obstruction/Occlusion
MAUDE report 11011470 ↗MalfunctionNov 16, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE INTEGRITY CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION EXHIBITING 60-70% STENOSIS IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) AND 99% IN THE DISTAL RIGHT CORONARY ARTERY (RCA), THE OSTIUM AND MID RCA WAS ALSO REQUIRED TO BE TREATED.. 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 ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. THE STENT WAS NOT REMOVED AND WAS DEPLOYED IN THE RIGHT ARM RADIAL ARTERY. IT WAS STATED THAT PER FLUOROSCOPY THE STENT APPEARED TO HAVE BEEN COMPROMISED DURING INITIAL ADVANCEMENT AGAINST SEVERE DIFFUSE CALCIFICATION AND AN ATTEMPT TO WITHDRAW THE STENT DUE TO NO CROSS FAILED. IT IS POSSIBLE THAT THE PROXIMAL STRUTS CAUGHT ON THE GUIDE LUMEN AND THEREFORE MAKING A WITHDRAWAL THROUGH THE GUIDE AND SHEATH IMPOSSIBLE. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10842264 ↗MalfunctionNov 4, 2020Inflation Problem; Inflation Problem
DURING THE PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE INTEGRITY RX CORONARY DRUG ELUTING STENT TO TREAT A LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. IT WAS REPORTED THAT INFLATION DIFFICULTIES OCCURRED DURING BALLOON INFLATION. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURIES.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10783688 ↗DeathAug 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DURING A PROCEDURE, TWO RESOLUTE INTEGRITY RX CORONARY DRUG ELUTING STENTS WERE IMPLANTED TO TREAT LESIONS. IT WAS REPORTED THAT THE PATIENT DECEASED 5 YEARS POST IMPLANTATION OF THE RESOLUTE INTEGRITY STENTS. IT WAS STATED THAT THE CAUSE OF DEATH WAS CHOLECYSTITIS.
Patient problems: Death; Inflammation
MAUDE report 10395004 ↗DeathAug 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DURING A PROCEDURE, TWO RESOLUTE INTEGRITY RX CORONARY DRUG ELUTING STENTS WERE IMPLANTED TO TREAT LESIONS. IT WAS REPORTED THAT THE PATIENT DECEASED 5 YEARS POST IMPLANTATION OF THE RESOLUTE INTEGRITY STENTS. IT WAS STATED THAT THE CAUSE OF DEATH WAS CHOLECYSTITIS.
Patient problems: Death; Inflammation
MAUDE report 10395002 ↗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 ↗InjuryMay 6, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE INTEGRITY RX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, MILDLY CALCIFIED LESION LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). 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 ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. IT WAS STATED THAT THE DISLODGED STENT WAS VISIBLE IN THE PROXIMAL RCA. THE DISLODGED STENT WAS ATTEMPTED TO BE REMOVED MULTIPLE TIMES USING A SNARE AND AN ATTEMPT TO DEPLOY A NON-MEDTRONIC STENT ALSO FAILED. IT WAS STATED THAT A NON-MEDTRONIC STENT WAS FIRST DEPLOYED IN THE PROXIMAL LESION AND ADDITIONAL NON-MEDTRONIC STENTS WERE ATTEMPTED TO BE DELIVERED TO THE MID RCA LESION BUT FAILED AND WERE REMOVED SUCCESSFULLY. IT WAS STATED THAT ADDITIONAL DILATION WAS COMPLETED AND AN ATTEMPT TO DELIVER THE RESOLUTE INTEGRITY STENT FAILED. IT WAS STATED THAT AFTER THE 3RD FAILED DELIVERY OF THE RESOLUTE INTEGRITY STENT THE WIRE AND GUIDE WERE REMOVED. A NEW GUIDE AND WIRE WERE INS
Patient problems: Injury
MAUDE report 10027953 ↗MalfunctionFeb 26, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE INTEGRITY RX CORONARY DRUG ELUTING STENT TO TREAT A DIAGONAL LESION. IT WAS REPORTED THAT THE STENT FAILED TO CROSS THE LESION. IT WAS STATED THAT THE STENT CAME OFF THE BALLOON CATHETER INSIDE THE GUIDE CATHETER WHEN REMOVING THE DEVICE FROM THE ARTERY. THE PROCEDURE WAS COMPLETED USING ANOTHER STENT OF THE SAME SIZE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9754966 ↗InjuryFeb 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT IS REPORTED THAT A PATIENT HAD TWO RESOLUTE INTEGRITY DRUG-ELUTING STENTS IMPLANTED. IT IS REPORTED THAT THE PATIENT WAS HAVING BREAKOUTS AND A RASH THAT WAS GETTING WORSE, SINCE HAVING THE DEVICES IMPLANTED. IT IS STATED THAT THE PATIENT HAD TESTED POSITIVE FOR ALLERGIES TO NICKEL AND CHROMIUM.
Patient problems: Reaction; Unspecified Infection
MAUDE report 9726657 ↗
Other Medtronic, Inc. products
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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