Onyx Frontier™ ONYXNG30018UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00763000511487), received between Mar 16, 2023 and Aug 12, 2025 — classified as 1 death, 3 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (7 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• DeathAug 12, 2025Difficult to Remove; Device Dislodged or Dislocated; Positioning Problem; Difficult to Remove; Device Dislodged or Dislocated; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG-ELUTING STENT, THE STENT DISLODGED FROM THE BALLOON. THE DISLODGMENT OCCURRED DURING REMOVAL OF THE DEVICE. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) HAD HIGH CALCIFICATION WITH 40% STENOSIS IN PROXIMAL AND 75% IN MID, THE LEFT MAIN (LM) HAD 60% STENOSIS WITH PROXIMAL FIBRO CALCIFICATION, THE FIRST DIAGONAL HAD 40% STENOSIS AND THE CIRCUMFLEX (CX) HAD 95% STENOSIS. THE LESION BEING TREATED WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED ADVANCING THE DEVICE AND NO EXCESSIVE FORCE WAS USED. ATTEMPTS TO REMOVE THE STENT BY SNARING AND USING SMALLER BALLOONS THROUGH THE STENT WERE UNSUCCESSFUL AND THE STENT WAS NOT ABLE TO BE REMOVED. NO RESISTANCE WAS ENCOUNTERED WITHDRAWING THE DEVICE AND NO EXCESSIVE FORCE WAS USED. CARDIAC SURGERY, WHICH WAS OFF-SITE WAS CALLED. CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED FOR THIRTY-FIVE (35) MINUTES AND THE PATIENT WAS RESUSCITATED TWICE. DUE TO BLOCKED ILIACS IT WAS NOT POSSIBLE TO PLACE BALLOON AND DUE TO B

  Patient problems: Cardiac Arrest; Cardiogenic Shock; Coronary obstruction/occlusion; Device Embedded In Tissue or Plaque

  MAUDE report 22781012 ↗
• MalfunctionAug 5, 2025Material Deformation; Positioning Problem; Material Deformation; Positioning Problem

  IT WAS REPORTED THAT ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT FAILED TO CROSS THE LESION AND STENT DEFORMATION OCCURRED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22713701 ↗
• MalfunctionMay 12, 2025Burst Container or Vessel; Improper or Incorrect Procedure or Method; Burst Container or Vessel; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT A RUPTURE OF THE STENT DELIVERY BALLOON OCCURRED. IT WAS NOTED THAT BLOOD WAS FLOWING INTO THE INFLATION DEVICE WHEN THE DEVICE WAS BEING NEGATIVELY PREPPED AT THE LESION. NEGATIVE ATM WAS APPLIED WHEN THE RUPTURE OCCURRED, AND IT WAS NOT POSSIBLE TO PULL NEGATIVE TO PREP THE STENT INSIDE THE PATIENT DUE TO THE RUPTURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22002805 ↗
• InjuryApr 28, 2025Device Dislodged or Dislocated; Positioning Problem; Device Dislodged or Dislocated; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT, THE STENT CAME OFF THE DELIVERY SYSTEM DURING REMOVAL. THE TARGET LESION WAS SEVERELY TORTUOUS, SEVERELY CALCIFIED IN THE OSTIUM OF THE LEFT MAIN (LM) CORONARY ARTERY. THE DEVICE WAS NOT INSPECTED PRIOR TO USE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE STENT WOULDN'T PASS THROUGH THE LEFT CIRCUMFLEX (LX) ARTERY AND CAME OFF THE DELIVERY SYSTEM IN THE LM DURING ATTEMPTS TO REMOVE THE DEVICE. THE DISLODGED STENT WAS SUCCESSFULLY REMOVED FROM THE LM. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21916744 ↗
• InjuryFeb 26, 2025Difficult to Remove; Device Dislodged or Dislocated; Material Deformation; Positioning Problem; Difficult to Remove; Device Dislodged or Dislocated; Material Deformation; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG-ELUTING STENT, THE STENT DISLODGED DURING REMOVAL FOLLOWING A FAILED DELIVERY. THE STENT FAILED TO CROSS THE LESION AND STRIPPED OFF THE BALLOON INTO THE LEFT MAIN ARTERY (LM). IT WAS BELIEVED THAT THE STENT COULD POSSIBLY NOT BE DELIVERED DUE TO A STENT STRUT IN THE OSTIUM OF THE DIAGONAL BRANCH STICKING OUT INTO LEFT ANTERIOR DESCENDING ARTERY (LAD) AND WHEN IT WAS THEN ATTEMPTED TO REMOVE THE STENT, IT DISLODGED INTO THE LM. THE STENT WAS UNABLE TO BE REMOVED FROM THE PATIENT AND WAS CRUSHED IN THE LM. ADDITIONAL DILATION WAS PERFORMED AND THE LESION WAS STENTED WITH A NON-MEDTRONIC STENT WITH A LOWER PROFILE WHICH WAS ABLE TO CROSS. THE LESION BEING TREATED WAS A NON-TORTUOUS AND NON-CALCIFIED LESION WITH 70% STENOSIS IN THE PROXIMAL LAD. THE DEVICE WAS INSPECTED PRIOR TO USE AND NEGATIVE PREPARATION WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information

  MAUDE report 21466945 ↗
• MalfunctionSep 16, 2024Material Deformation; Material Deformation

  TWO 3.0X18MM ONYX FRONTIER DRUG ELUTING STENTS WERE RETURNED FOR EVALUATION. THERE WAS NO REPORTED COMPLAINT AGAINST THESE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20232750 ↗
• MalfunctionSep 16, 2024Material Deformation; Material Deformation

  TWO 3.0X18MM ONYX FRONTIER DRUG ELUTING STENTS WERE RETURNED FOR EVALUATION. THERE WAS NO REPORTED COMPLAINT AGAINST THESE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20229944 ↗
• InjurySep 10, 2024Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Detachment of Device or Device Component

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS, MODERATELY CALCIFIED LESION WITH 80% LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED 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. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. THE DEVICE WAS KINKED AND RE-STRAIGHTENED DURING USE. IT WAS REPORTED THAT THE CATHETER SHAFT BROKE DURING ADVANCEMENT THROUGH THE GUIDE CATHETER. THE CATHETER OF THE STENT WAS SLIGHTLY BENT DURING INSERTION THROUGH THE TOUHY VALVE, BUT THE CATHETER WAS STRAIGHTENED A BIT AND CONTINUED TO BE USED. THE CATHETER WAS EASILY ADVANCED THROUGH THE GUIDE CATHETER AND TELESCOPE GUIDE EXTENSION CATHETER. ONCE THE DEVICE WAS ACROSS THE LESION OF THE PROXIMAL TO MID RCA, THE DEVICE WAS PUT IN NEGATIVE ON THE BALLOON TO MAKE SURE THERE WERE NO ISSUES. ONCE THE DEVICE WAS PUT IN NEGATIVE THERE WAS EVIDENCE OF BLOOD RETURN IN THE INFLATION DEVICE. AN ATTEMPT WAS THEN MADE TO SLIGHTLY AND GENTLY REMOVE THE STENT CATHETER WHEN IT WAS NOTICED THAT THE DISTAL

  Patient problems: Insufficient Information

  MAUDE report 20179173 ↗
• MalfunctionAug 15, 2024Deformation Due to Compressive Stress; Device Dislodged or Dislocated; Material Deformation; Positioning Problem; Deformation Due to Compressive Stress; Device Dislodged or Dislocated; Material Deformation; Positioning Problem

  AN ATTEMPT WAS MADE TO USE ONE 2.75 X 26 MM ONYX FRONTIER DRUG ELUTING STENT TO TREAT A MODERATELY CALCIFIED LESION IN THE OSTIUM OF THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 3.0 X 22MM ONYX FRONTIER STENT AND A 3.0 X 18MM ONYX FRONTIER STENT WERE ALSO ATTEMPTED TO BE USED DURING THE PROCEDURE TO TREAT A LESION. THE DEVICES WERE INSPECTED BEFORE USE WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE 3.0 X 22MM ONYX FRONTIER STENT AND A 3.0 X 18MM ONYX FRONTIER STENT WERE PREPPED PER IFU WITH NO ISSUES NOTED. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE 2.75 X 26 MM ONYX FRONTIER STENT AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE 2.75 X 26 MM ONYX FRONTIER STENT CAME OFF THE BALLOON DURING WITHDRAWAL OF THE DEVICE. THE STENT WAS BEING ATTEMPTED TO BE DEPLOYED BUT IT CAME OFF THE BALLOON AND HAD TO RETRIEVED OUT OF THE VESSEL BY SNARE. ONE 3.0 X 22MM ONYX FRONTIER STENT WAS ALSO REPORTED TO BE COMING OFF THE BALLOON BUT WAS ABLE TO BE SUCCESSFULLY DEPLOYED AND IMPLANTED IN THE PATIENT. INTRAVASCULAR LITHOTRIPSY (IVL) WAS PERFORMED FIRST, THEN THE STENT CAME OFF THE NON MEDTRONIC WIR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19990971 ↗
• MalfunctionJan 26, 2024Device Dislodged or Dislocated; Positioning Problem; Device Dislodged or Dislocated; Positioning Problem

  AN ATTEMPT WAS MADE TO USE TWO ONYX FRONTIER CORONARY DRUG-ELUTING STENTS TO TREAT A LESION WITH 70% STENOSIS IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. THE DEVICES PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE TWO STENTS FAILED TO CROSS THE LESION. IT WAS DETAILED THAT ONE OF THE ONYX FRONTIER STENT'S WAS UNABLE TO ADVANCE THROUGH THE EXISTING STENT AND UPON PULLING OUT OF THE SHEATH, THE STENT CAME OFF THE CATHETER. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18586954 ↗
• MalfunctionApr 20, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT NON-TORTUOUS, MILDLY CALCIFIED LESION WITH 90% STENOSIS, LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. IT WAS REPORTED THAT STENT DISLODGED OCCURRED DURING SHEATH REMOVAL. THE STENT DISLODGED OFF THE DELIVERY SYSTEM BEFORE ENTERING THE PATIENT'S BODY. IT WAS DETAILED THAT THE STENT CATHETER WAS INSERTED INTO THE MID LAD, BUT IT WAS DISCOVERED THAT THE STENT WAS NOT SEEN ON FLUOROSCOPY. THE ENTIRE BODY WAS SCANNED TO FIND THE STENT, BUT IT WAS NOT LOCATED IN THE BODY. THEN THE GUIDE AND WIRE WERE REMOVED OUT OF THE BODY AND FLUSHED TO SEE IF THE STENT WAS INSIDE, BUT IT WAS NOT FOUND. THE STENT WAS LATER FOUND IN THE PROTECTIVE PLASTIC SHEATH COVER. THE STENT WAS STUCK INSIDE THE COVER. THE STENT DID NOT ENTER THE PATIENT. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16774847 ↗
• MalfunctionMar 16, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT PRESENTED TO HOSPITAL WITH CARDIOGENIC SHOCK. AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG-ELUTING STENT TO TREAT A SEVERELY CALCIFIED LESION WITH 95% STENOSIS IN THE PROXIMAL FIRST OBTUSE MARGINAL (OM1) ARTERY. THERE WERE NO ISSUES NOTED WITH THE PACKAGING OR HOOP. THERE WERE NO ISSUES NOTED REMOVING THE DEVICE FROM THE HOOP. NEGATIVE PREP WAS NOT PERFORMED. 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 DELIVERY TO/AT THE LESION. THERE WAS DIFFICULTY EXPERIENCED TRACKING THE STENT OVER THE WIRE. IT WAS DETAILED THAT THE STENT DID NOT MAKE IT OUT OF THE GUIDE CATHETER. THE STENT WAS REMOVED THE GUIDE CATHETER. IT WAS THEN NOTICED THAT THE STENT WAS NOT ON THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER NON-MEDTRONIC STENT. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16551298 ↗