Resolute Onyx™ RONYX20026UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00643169556676), received between Sep 21, 2018 and Mar 20, 2026 — classified as 5 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (9 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT, STENT DISLODGEMENT OCCURRED AFTER REMOVAL FROM THE PATIENT. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24647224 ↗
• MalfunctionDec 18, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS RETURNED. NO DEVICE MALFUNCTION WAS REPORTED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18345117 ↗
• InjuryMar 1, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED LESION WITH 100% STENOSIS IN THE DIAGONAL BRANCH OF THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. IT WAS STATED THAT THE DIAGONAL WAS 100% OCCLUDED. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PREFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED, DURING REMOVAL FOLLOWING FAILED DELIVERY. THE STENT WAS DISLODGED WITH HALF IN THE LAD AND HALF IN THE DIAGONAL. A BALLOON WAS USED TO EXPAND STENT IN PLACE. THE STENT REMAINS IN THE PATIENT. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information

  MAUDE report 13631836 ↗
• InjuryJun 16, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS ATTEMPTED TO BE USED TO TREAT A LESION IN THE CIRCUMFLEX (CX) ARTERY. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. THE DISLODGED STENT WAS NOT REMOVED, IT WAS CRUSHED BY ANOTHER STENT. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12007050 ↗
• InjuryJun 3, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS ATTEMPTED TO BE USED TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION WITH 60% STENOSIS IN THE OSTIUM OF THE 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. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS STATED THAT NO BALLOON WENT EASY BUT THERE WAS DIFFICULTY WITH THE STENT AND IT WAS LOSING GUIDE POSITION. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED AT THE OSTIUM OF THE VESSEL DURING DELIVERY TO THE LESION. AN ATTEMPT WAS MADE TO REMOVE THE STENT USING A SNARE BUT WAS UNSUCCESSFUL. THE STENT WAS THEN DEPLOYED USING A COMPLIANT BALLOON AND A NON-COMPLIANT BALLOON. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11929621 ↗
• MalfunctionMar 26, 2021Material Deformation; Material Deformation

  ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS ATTEMPTED TO BE USED DURING A PROCEDURE TO TREAT A SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION IN THE PROXIMAL 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 BUT EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING. THE PROCEDURE WAS COMPLETED USING A POBA DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11573667 ↗
• MalfunctionNov 2, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A RESOLUTE ONYX DES WAS USED DURING A PROCEDURE TO TREAT A MODERATE CALCIFIED, MILD TORTUOUS LESION EXHIBITING 95% STENOSIS IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED. IT WAS REPORTED THAT THE STENT DISLODGED OCCURRED FOLLOWING A FAILED DELIVERY. AN ATTEMPT WAS MADE TO EXTRACT THE DISLODGED STENT WITH A 0.14 WIRE BUT FAILED. A NON MEDTRONIC STENT WAS USED TO STENT OVER THE DISLODGED RESOLUTE ONYX DES AND CRUSH INTO THE VESSEL WALL. THE PATIENT IS ALIVE WITH NO INJURY. THE INTERVENTIONAL PROCEDURE WAS COMPLETED WITH NO PATIENT ISSUE TO DATE.

  Patient problems: Insufficient Information; No Consequences Or Impact To Patient

  MAUDE report 10769511 ↗
• MalfunctionSep 4, 2020Device Dislodged or Dislocated; Positioning Problem; Device Dislodged or Dislocated; Positioning Problem

  A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT WAS USED DURING A PROCEDURE TO TREAT A LESION IN THE MID CIRCUMFLEX ARTERY. IT WAS RE PORTED THAT THE STENT FAILED TO CROSS THE LESION AND THE STENT CAME OFF THE BALLOON. THE STENT WAS NOT DEPLOYED. THERE IS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10493100 ↗
• InjuryFeb 17, 2020Device 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 LESION LOCATED IN THE SECOND DIAGONAL BRANCH. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. IT WAS STATED THAT THE STENT FELL OF THE GUIDER. IT IS UNKNOWN IF THE STENT DISLODGEMENT OCCURRED IN VITRO OR IN VIVO. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9716194 ↗
• MalfunctionNov 19, 2019Material Deformation; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITHOUT ISSUE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE STENT. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING, THE STENT BECAME STUCK IN A GUIDE EXTENSION CATHETER AND BECAME DEFORMED. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9340318 ↗
• MalfunctionNov 12, 2019Material Deformation; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT. IT WAS INDICATED THAT THE STENT FAILED TO CROSS THE LESION AND STENT DEFORMATION OCCURRED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9310220 ↗
• MalfunctionJul 11, 2019Material Deformation; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A LESION IN THE PROXIMAL CIRCUMFLEX (CX) ARTERY. IT WAS INDICATED THAT THE STENT WAS UNABLE TO CROSS THE LESION AND ON REMOVAL OF THE DEVICE THERE WERE STRUTS OF THE STENT NOTED TO BE BENT. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8779962 ↗
• InjuryDec 5, 2018Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  DURING A PROCEDURE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT WAS USED TO TREAT A LESION. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT THE LESION. NO PATIENT INJURY IS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient; Patient Problem/Medical Problem

  MAUDE report 8132235 ↗
• MalfunctionSep 21, 2018Material Deformation; Material Deformation

  DURING THE PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A LESION LOCATED IN THE MID OBTUSE MARGINAL (OM). THERE WERE NO ABNORMALITIES IN RELATION TO THE ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE DILATED. IT WAS REPORTED THAT THE DEVICE FAILED TO CROSS THE LESION AND STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING. THE PROCEDURE WAS COMPLETED USING A BALLOON. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7896934 ↗