Resolute Onyx™ RONYX40038UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00643169557222), received between Jan 5, 2018 and Sep 30, 2026 — classified as 1 death, 13 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Difficult to Remove; Device Damaged by Another Device; Difficult to Advance; Device Dislodged or Dislocated; Material Deformation

  Percutaneous coronary intervention (PCI) procedure on the right coronary artery (RCA) was performed via right radial access to treat obstructive RCA disease. The lesion being treated was mildly tortuous, mildly calcified, with 75% stenosis located in the proximal Right Coronary Artery (RCA). The lesion was noted to be eccentric, irregular and ulcerative. The was a previously deployed stent present. There was a severe plaque burden detected. A guide catheter was inserted, and the guidewire was advanced distal to the lesion. Angioplasty was performed prior to stent deployment. A 3.0 x 12 mm Euphora balloon was inflated to a maximum pressure of 16 ATM for a maximum of 20 seconds. Another 3.0 x 12 mm Euphora balloon was inflated to a maximum pressure of 14 ATM for a maximum of 20 seconds. A 4.0 x 38 mm Resolute Onyx coronary drug eluting stent (DES) was successfully advanced and deployed in the midlesion. The 4.0 x 38 mm Resolute Onyx stent was then advanced to treat the proximal lesion with overlap. The device was inspected prior to use with no issues. Negative prep was not performed. The device did not pass through a previously deployed stent. There was resistance encountered when ad

  Patient problems: Foreign Body Embolism; Hemorrhage/Blood Loss/Bleeding; Obstruction/Occlusion

  MAUDE report 50944401 ↗
• InjuryFeb 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TWO RESOLUTE ONYX WERE IMPLANTED ON THE (B)(6) 2022. THE PATIENT REPORTED A RASH ALL OVER THE BODY 14 DAYS AFTER THE TWO STENTS WERE IMPLANTED. THE PATIENT PREVIOUSLY HAD TWO NON-MEDTRONIC STENT IMPLANTED ON THE (B)(6) 2022 WITH NO ISSUES. THE CARDIOLOGIST AND DERMATOLOGIST WERE INFORMED OF THE RASH AND THE PATIENT HAS BEEN REFERRED TO THEIR DOCTOR. THE PATIENT UNDERWENT SKIN TESTING WHICH WAS POSITIVE FOR COBALT. THE PATIENT HAS KNOWN PENICILLIN AND SHRIMP ALLERGY. A ZOTOROLIMUS ALLERGY IS SUSPECTED, HOWEVER, IT WAS NOT KNOWN BEFORE. MEDICATIONS OMEPRIZOL AND LIPITOR HAVE BEEN DISCONTINUED, AND OTHER MEDICATIONS HAVE BEEN SWITCHED AROUND TO HELP, BUT THE RASH PERSISTED. THE PATIENT IS TAKING AN ANTIHISTAMINE ZYRTEC FOR THEIR SYMPTOMS. THE RASH IS SINCE IMPROVED AND THE PATIENT IS DOING FINE.

  Patient problems: Local Reaction; Rash

  MAUDE report 16402283 ↗
• InjuryNov 8, 2022Fracture; Fracture

  TWO RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT WERE IMPLANTED. THE PATIENT REPORTED EXPERIENCING DISCOMFORT AND IT WAS NOTICED THAT ONE OF THE IMPLANTED STENTS WAS FRACTURED. THE FRACTURED STENT WAS REPAIRED WITH A NON-MEDTRONIC STENT. IT IS NOT KNOWN WHICH ONE OF THE TWO RESOLUTE ONYX STENTS FRACTURED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Discomfort; Insufficient Information

  MAUDE report 15750818 ↗
• InjuryJun 7, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED LESION LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. 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 STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT A LESION. IT WAS STATED THAT THE DISLODGED STENT WAS NOT REMOVED AND A SMALL BALLOON WAS DELIVERED TO DEPLOY THE STENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information

  MAUDE report 14619118 ↗
• MalfunctionApr 27, 2022Material Deformation; Material Deformation

  ONE 6F TELESCOPE GUIDE EXTENSION CATHETER (GEC) AND ONE 4.0X38MM RESOLUTE ONYX CORONARY DRUG ELUTING STENT WERE ATTEMPTED TO BE USED TO TREAT A SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 99% STENOSIS IN THE MID RIGHT CORONARY ARTERY (RCA). THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THE DEVICES WERE REMOVED FROM THE PACKAGING PER IFU. THE DEVICES WERE INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE TELESCOPE WAS PREPPED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED ON THE RESOLUTE ONYX DEVICE. THE LESION WAS PRE-DILATED. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE TELESCOPE AND EXCESSIVE FORCE WAS NOT USED. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE RESOLUTE ONYX, EXCESSIVE FORCE WAS NOT USED.  THE RESOLUTE ONYX STENT WAS ATTEMPTED TO BE DELIVERED TO THE LESION BUT IT FAILED TO CROSS SO WAS REMOVED FROM THE PATIENT. THE TELESCOPE DEVICE WAS THEN ADVANCED AND FURTHER PRE-DILATION WAS PERFORMED AT THE LESION. THE RESOLUTE ONYX WAS ADVANCED AGAIN BUT THIS TIME WOULD NOT ADVANCE THROUGH THE ENTRY PORT OF THE TELESCOPE. IT WAS REPORTED THAT THE LOADING RAMP OF THE TELESCOPE WAS NOTED TO BE PEEL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14218836 ↗
• InjuryJan 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT AND ONE NC EUPHORA BALLOON CATHETER WERE USED TO TREAT A MILDLY TORTUOUS, MODERATELY CALCIFIED LESION WITH 90% STENOSIS IN THE MID RIGHT CORONARY ARTERY (RCA). A TELESCOPE GUIDE EXTENSION CATHETER WAS ALSO USED. THE RESOLUTE ONYX DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE NC EUPHORA DEVICE WAS NOT INSPECTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE RESOLUTE ONYX BUT EXCESSIVE FORCE WAS NOT USED. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE NC EUPHORA AND EXCESSIVE FORCE WAS NOT USED. THE RESOLUTE ONYX STENT WAS IMPLANTED AND POST-DILATED USING THE NC EUPHORA. IT WAS REPORTED THAT THERE WAS AN ANEURYSM AND A PERFORATION ON THE SMALL BRANCH COMING OFF THE RCA. PATIENT IS STABLE AND DOING FINE. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Aneurysm; Perforation

  MAUDE report 13288028 ↗
• InjuryJan 12, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY CALCIFIED, SEVERELY TORTUOUS LESION WITH 85% STENOSIS LOCATED IN THE OSTIUM OF THE RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED BEFORE USE WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION. THE DISLODGED STENT WAS REMOVED WITH A SNARE. NO FURTHER INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 13237064 ↗
• MalfunctionJun 24, 2021Use of Device Problem; Use of Device Problem

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A LESION. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OR ANY ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. IT WAS REPORTED THAT THE DEVICE WAS USED AFTER THE EXPIRY DATE. IT WAS STATED THAT THE EXPIRED STENT WAS PULLED OFF THE SHELF BY SALES REP AND SUBMITTED AS A CONSIGNMENT EXCHANGE. THE BOXES WERE LABELLED AS "SHORT DATE" AND TAPED. HOWEVER, THE STENT WAS PLACED BACK ON THE SHELF BY STAFF AT THE ACCOUNT, RESULTING IN IMPLANTATION OF EXPIRED STENT IN PATIENT¿S BODY. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12056272 ↗
• MalfunctionMar 30, 2021Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. IT WAS REPORTED THAT REMOVAL DIFFICULTIES OCCURRED AND DIFFICULTY REMOVING THE DEVICE FOLLOWING STENT DEPLOYMENT WAS EXPERIENCED. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11587427 ↗
• MalfunctionDec 8, 2020Material Deformation; Material Deformation

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A CALCIFIED LESION LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE LESION WAS PRE-DILATED. RESISTANCE WAS NOTED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THE STENT FAILED TO CROSS THE LESION AND UPON INSPECTION STENT DEFORMATION WAS NOTED TO THE DISTAL END OF THE STENT. THE PROCEDURE WAS COMPLETED USING ANOTHER STENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10964740 ↗
• InjuryMar 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE, TWO RESOLUTE ONYX DES WERE IMPLANTED IN THE RCA. ON THE SAME DAY POST INDEX PROCEDURE, PATIENT SUFFERED FROM MYOCARDIAL INFARCTION. EVENT WAS TREATED WITH PCI. INVESTIGATOR ASSESSED THAT THE EVENT WAS UNLIKELY RELATED TO INDEX DEVICE AND NOT RELATED TO ANTIPLATELETS MEDICATION. SAFETY ASSESSED THAT THE EVENT WAS NOT RELATED TO INDEX DEVICE OR ANTIPLATELETS MEDICATION. CEC ADJUDICATED THE EVENT AS MI (TARGET VESSEL). CEC COMMENTED THAT THE FILM WAS REVIEWED AND OCCLUSION OF THE RV MARGINAL BRANCH WAS NOTED.

  Patient problems: Myocardial Infarction; Occlusion

  MAUDE report 9847333 ↗
• DeathMar 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE, THREE RESOLUTE ONYX DRUG-ELUTING STENTS WERE IMPLANTED : ONE IN THE IN THE R-PDA AND TWO IN THE RCA. APPROXIMATELY 8 MONTHS POST PROCEDURE, PATIENT DEATH OCCURRED. INVESTIGATOR AND SPONSOR ASSESSED EVENT IS NOT RELATED TO DEVICE OR ANTI PLATELET MEDICATION. CEC ADJUDICATED EVENT A CARDIAC DEATH.

  Patient problems: Death

  MAUDE report 9834648 ↗
• MalfunctionDec 13, 2019Difficult to Remove; Device Damaged by Another Device; Device Dislodged or Dislocated; Material Deformation; Difficult to Remove; Device Damaged by Another Device; Device Dislodged or Dislocated; Material Deformation

  A 6F TELESCOPE GUIDE EXTENSION CATHETER AND A 4.0 X 38 MM RESOLUTE ONYX WERE BEING USED DURING A PROCEDURE TO TREAT A MILDLY TORTUOUS, MODERATELY CALCIFIED LESION EXHIBITING 70% STENOSIS IN THE OSTIUM AND PROXIMAL OF THE LEFT MAIN (LM) CORONARY ARTERY AND LEFT ANTERIOR DESCENDING (LAD) ARTERY. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE TELESOPE DEVICE. THE TELESCOPE WAS REMOVED FROM THE HOOP AS PER IFU WITH NO ISSUES. BOTH THE TELESCOPE AND RESOLUTE ONYX STENT WERE INSPECTED WITH NO ISSUES. THE TELESCOPE WAS PREPPED AS PER IFU WITH NO ISSUES. THE LESION WAS NOT PREDILATED. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE TELESCOPE OR RESOLUTE ONYX DEVICES. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY OF THE TELESCOPE OR RESOLUTE ONYX DEVICE. THE FIRST TELESCOPE DEVICE WAS USED TO SECURE ACCESS TO THE LEFT MAIN ARTERY WHILE IMPLANTING THE COREVALVE DEVICE. A SECOND TELESCOPE DEVICE AND A STENT WERE USED TO PROTECT THE RIGHT CORONARY. THERE WERE NO ISSUES WITH THE SECOND TELESCOPE DEVICE USED TO PROTECT THE RIGHT CORONARY ARTERY. THERE WAS AN OLD SURGICAL NON-MEDTRONIC VALVE AND A PREVIOUSLY DEPLOYED COREVALVE THAT WERE ALREADY IMPLANTED IN THE PAST. BOTH OF THOSE VALVES HAD

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9465045 ↗
• InjuryOct 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE, TWO RESOLUTE ONYX DRUG-ELUTING STENTS WERE IMPLANTED IN THE GRAFT R-PDA. APPROXIMATELY 6 MONTHS POST PROCEDURE, PATIENT SUFFERED STEMI WHICH IS RELATED TO MYOCARDIAL INFARCTION OF THE TARGET VESSEL RCA. EVENT WAS TREATED WITH AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. PATIENT RECOVERED. INVESTIGATOR ASSESSED EVENT IS NOT RELATED TO DEVICE OR ANTI PLATELET MEDICATION. SPONSOR ASSESSED EVENT IS POSSIBLY RELATED TO DEVICE BUT NOT RELATED TO ANTI PLATELET MEDICATION.

  Patient problems: Myocardial Infarction

  MAUDE report 9155243 ↗
• InjuryJul 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO RESOLUTE ONYX DES WERE IMPLANTED IN THE RCA. AFTER THE INDEX PROCEDURE THE PATIENT HAD ST ELEVATION AND CHEST PAIN WHICH RESOLVED AT PRESENTATION TO THE CATH LAB. REVASCULARISATION WAS PERFORMED BY IMPLANTING TWO RESOLUTE ONYX DES IN THE RCA ON THE SAME DAY. CEC ADJUDICATED A NON Q WAVE TARGET VESSEL MI 3RD UDMI PERI-PCI AND THE REVASC AS CLINICALLY DRIVEN TLR.

  Patient problems: Myocardial Infarction

  MAUDE report 8845643 ↗
• InjuryJun 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO RESOLUTE ONYX STENTS WERE IMPLANTED INTO THE RCA. APPROX 22 MONTHS POST INDEX PROCEDURE THE PATIENT SUFFERED SUBARACHNOID HEMORRHAGE. THE PATIENT WAS TREATED WITH A CHANGE IN MEDICATION. THE PATIENT RECOVERED. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE OR ANTI-PLATELET MEDICATION. SAFETY ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE BUT POSSIBLY RELATED TO ANTI-PLATELET MEDICATION.

  Patient problems: Stroke/CVA

  MAUDE report 8744108 ↗
• InjuryApr 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO RESOLUTE ONYX STENTS WERE IMPLANTED TO TREAT THE RCA. APPROXIMATELY 6 DAYS POST INDEX PROCEDURE THE PATIENT SUFFERED ARM DISCOMFORT. IT WAS REPORTED THAT THE PATIENT MAY HAVE SUFFERED A POSSIBLE EMBOLIC EVENT. STROKE DID NOT OCCUR. THE INVESTIGATOR AND SAFETY ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE OR ANTI-PLATELET MEDICATION. THE PATIENT IS RECOVERING.

  Patient problems: Embolism; Stroke/CVA

  MAUDE report 8564645 ↗
• MalfunctionJul 24, 2018Break; Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING THE USE OF A RESOLUTE ONYX DRUG ELUTING STENT IT WAS REPORTED THAT THE CATHETER BROKE INSIDE THE GUIDE CATHETER.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7713285 ↗
• MalfunctionMay 16, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT IS REPORTED THAT A RESOLUTE ONYX DRUG ELUTING STENT DISLODGED WITHIN THE BODY DURING A PROCEDURE. A CT CONFIRMED THAT THE STENT HAD MIGRATED TO THE RIGHT CALF BUT DID NOT REQUIRE RETRIEVAL.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7517587 ↗
• InjuryJan 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE RESOLUTE ONYX DES WERE USED TO TREAT THE PROXIMAL, MIDDLE AND DISTAL RCA AND THE RIGHT POSTERIOR DESCENDING ARTERY (R-PDA). APPROXIMATELY 5 MONTHS POST INDEX PROCEDURE THE PATIENT SUFFERED AN ACUTE CVA.

  Patient problems: Stroke/CVA

  MAUDE report 7166978 ↗
• InjuryJan 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE RESOLUTE ONYX DES WERE USED TO TREAT THE PROXIMAL, MIDDLE AND DISTAL RCA AND THE RIGHT POSTERIOR DESCENDING ARTERY (R-PDA). APPROXIMATELY 5 MONTHS POST INDEX PROCEDURE THE PATIENT SUFFERED AN ACUTE CVA.

  Patient problems: Stroke/CVA

  MAUDE report 7166975 ↗