Onyx Frontier™ ONYXNG35012UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00763000511555), received between Oct 21, 2022 and May 1, 2026 — classified as 9 injuries, 4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryMay 1, 2026Device Dislodged or Dislocated

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE TWO ONYX FRONTIER CORONARY DRUG ELUTING STENTS WHEN THE DEVICES BECAME DISLODGED IN-VIVO DURING DELIVERY TO/AT LESION. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICES FROM THE HOOP/TRAY. THE DEVICES WERE INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE LESION BEING TREATED WAS A SEVERELY TORTUOUS, MODERATELY CALCIFIED LESION LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICES, AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE STENTS WERE NOT REMOVED FROM THE PATIENT. WITH BOTH STENTS, THE STENT WAS RE-WIRED AND DEPLOYED USING MULTIPLE BALLOONS AND ADDITIONAL SAME SIZE STENTS. NEW STENTS OF THE SAME SIZE WERE PLACED. PATIENT NOW HAS DOUBLE LAYERED STENTS IN 2 PORTIONS OF THE RCA. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 25055992 ↗
• MalfunctionDec 22, 2025Material Deformation; Positioning Problem; Material Deformation; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT, A STENT STRUT WAS FOUND TO BE STICKING OUT WHEN THE STENT WAS REMOVED AFTER A FAILED DELIVERY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23861933 ↗
• InjurySep 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, THE CATHETER OF ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT DETACHED DURING ADVANCEMENT THROUGH THE GUIDE CATHETER. WHO HAD A 95% LESION STENOSIS IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE DEVICE WAS NOT KINKED AND RESTRAIGHTENED DURING USE. THE DETACHED PORTION OF THE DEVICE WAS SNARED AND REMOVED FROM THE GUIDE CATHETER. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY, EXHIBITING 95% STENOSIS, NO TORTUOSITY AND NO CALCIFICATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23015487 ↗
• MalfunctionJun 16, 2025Device Dislodged or Dislocated; Positioning Problem; Device Dislodged or Dislocated; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER DRUG ELUTING STENT (DES), STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. THE LESION WAS MODERATELY CALCIFIED, MILDLY TORTUOUS LOCATED IN THE OSTIUM SAPHENOUS VEIN GRAFT (SVG). DURING PRE-DILATION OF THE LESION, THE BALLOON REPEATEDLY SLIPPED OUT OR BACK INTO THE MAIN ARTERY. AFTER SEVERAL PRE-DILATIONS, THE STENT WAS PLACED AND, UPON INFLATION TO APPROXIMATELY 2 ATMS, BOTH THE STENT AND BALLOON POPPED OUT OF THE VESSEL. WHEN NEGATIVE PRESSURE WAS APPLIED AND AN ATTEMPT WAS MADE TO REMOVE THE STENT, THE STENT BECAME DISLODGED AT THE SHEATH DURING REMOVAL OF THE DELIVERY SYSTEM. IT WAS BELIEVED THAT THE STENT MIGRATED DISTALLY DOWN THE LEG AND REMAINED IN THE PATIENT. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. NO INTERVENTION WAS PERFORMED, AS IT WAS FELT THAT THE STENT HAD TRAVELED DISTAL FROM THE FEMORAL ACCESS SITE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22212491 ↗
• InjuryOct 30, 2024Device Dislodged or Dislocated; Positioning Problem; Device Dislodged or Dislocated; Positioning Problem

  AN ATTEMPT WAS MADE TO USE AN ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A NON TORTUOUS, SEVERELY CALCIFIED LESION IN THE MID 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 ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. THE LESION IN THE MID RCA WAS BEING WORKED ON USING A 7FR AL.75 GUIDE CATHETER AND A NON MEDTRONIC WIRE. AFTER THE LESION WAS PREDILATED USING A NON MEDTRONIC 3.5 X 15 MM BALLOON, SHOCKWAVE WAS USED TO TREAT THE LESION. WHEN ATTEMPTING TO CROSS THE LESION WITH THE ONYX FRONTIER STENT, IT WOULD NOT FULLY CROSS THE LESION. WHEN PULLING THE STENT BACK INTO THE GUIDE CATHETER, IT SHEARED OFF THE BALLOON. THE DISLODGED STENT WAS NOT REMOVED. A 3.5 X 8 MM NON MEDTRONIC BALLOON WAS PLACED INSIDE THE UNDEPLOYED STENT AND WAS USED TO SUCCESSFULLY OPEN THE STENT. THE DISLODGED STENT WAS DEPLOYED. IT WAS BELIEVED THAT THERE WAS POSSIBLY EXCESSIVE FORCE USED DUE

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

  MAUDE report 20567234 ↗
• MalfunctionSep 4, 2024Device Damaged by Another Device; Device Dislodged or Dislocated; Device Damaged by Another Device; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE 3.5X12MM ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS, MODERATELY CALCIFIED LESION WITH 90% STENOSIS IN THE PROXIMAL-MID-DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT STENT DISLODGEMENT/DISPLACEMENT OCCURRED DURING DELIVERY TO/AT LESION. A NON-MEDTRONIC GUIDE EXTENSION CATHETER WAS IN USE AND ONE 2.75X38MM STENT AND ONE 3.0X30MM STENT WERE PLACED. MULTIPLE BALLOONS WERE USED AFTER STENT PLACEMENT, AND IT IS BELIEVED THAT USE OF THE BALLOONS DEFORMED THE PROXIMAL EDGE OF THE SECOND STENT PLACED. WHEN THE 3.5X12MM ONYX FRONTIER WAS BEING PLACED, THE DEFORMED PROXIMAL EDGE OF THE SECOND STENT CAUSED THE ONYX FRONTIER TO CATCH WHEN SLIDING BACK INTO PLACE, AND THE ONYX FRONTIER STENT STARTED TO COME OFF THE BALLOON. THE STENT WAS DEPLOYED IN PLACE AT THE LOCATION AND DIDN'T PULL COMPLETELY OFF THE BALLOON. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20133192 ↗
• InjuryJan 31, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT WAS IMPLANTED TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED LESION WITH 80% STENOSIS IN THE OSTIUM LEFT ANTERIOR DESCENDING (LAD) ARTERY. 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 DURING THE DELIVERY. SEVEN WEEKS POST STENT IMPLANTATION THE PATIENT CAME BACK FOR ANOTHER LEFT HEART CATHETERIZATION PROCEDURE FOR RECURRENT NON-ST-ELEVATION MYOCARDIAL INFARCTION (NSTEMI). DURING THE PROCEDURE ISSUES AND SYMPTOMS WERE DISCOVERED. IT WAS REPORTED THAT PART OF THE IMPLANTED STENT HAD BROKEN OFF. A POLYMER POTENTIALLY CAME OFF, AND THE STENT THROMBOSED. THE DETACHED PORTION OF DEVICE DOES NOT REMAIN IN PATIENT. AN ASPIRATION CATHETER WAS USED TO REMOVE THE STENT PART THAT DETACHED. THE EXPLANTED PART HAS BEEN SENT TO PATHOLOGY. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Chest Pain; Device Embedded In Tissue or Plaque; Insufficient Information; Myocardial Infarction; Thrombosis/Thrombus

  MAUDE report 18612537 ↗
• InjuryNov 29, 2023Device Dislodged or Dislocated; Positioning Problem; Device Dislodged or Dislocated; Positioning Problem

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT IN THE DISTAL LEFT MAIN (LM) CORONARY ARTERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION. THE STENT WAS ATTEMPTED TO BE ADVANCED INTO THE LM BUT WOULD NOT DELIVER AND THE STENT CAME OFF THE BALLOON. THE DISLODGED STENT WAS REMOVED. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18225640 ↗
• MalfunctionNov 16, 2023Entrapment of Device; Device Dislodged or Dislocated; Material Deformation; Entrapment of Device; Device Dislodged or Dislocated; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A LESION. THE DEVICE WAS NOT INSPECTED BEFORE USE. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. RESISTANCE WAS ENCOUNTERED WHEN PRE-DILATING. RESISTANCE WAS NOT ENCOUNTERED WHEN DELIVERING THE STENT AS A NON-MEDTRONIC GUIDE EXTENSION CATHETER (GEC) WAS USED AFTER THERE WAS RESISTANCE WHEN PRE-DILATING. EXCESSIVE FORCE WAS NOT USED. THE DEVICE WAS NOT DELIVERED THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT THE STENT DISLODGED FROM THE DELIVERY SYSTEM WHILE ATTEMPTING TO DELIVER THE DEVICE TO THE LESION. WHEN THE STENT WAS NOT VIEWED UNDER FLUOROSCOPY THE DELIVERY SYSTEM WAS REMOVED AND THERE WAS NO STENT. THE NON-MEDTRONIC GEC WAS REMOVED, AND THE STENT WAS FOUND STUCK ON IT. THE DISLODGED STENT WAS REMOVED. THERE WAS NO INJURY TO THE PATIENT AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18148525 ↗
• InjurySep 8, 2023Burst Container or Vessel; Inflation Problem; Difficult to Remove; Activation, Positioning or Separation Problem; Burst Container or Vessel; Inflation Problem; Difficult to Remove; Activation, Positioning or Separation Problem

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT (DES) TO TREAT A LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. 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 INFLATION DIFFICULTIES OCCURRED DUE TO A RUPTURED BALLOON. IT WAS DETAILED THAT THE STENT DID NOT FULLY DEPLOY DUE TO THE RUPTURED BALLOON. ONLY THE PROXIMAL PORTION OF THE STENT COULD BE FULLY DEPLOYED, BUT IT WAS NOT POSSIBLE TO DEPLOY THE MID TO DISTAL PORTION OF THE STENT. IT WAS EXTREMELY DIFFICULT TO PULL BACK THE BALLOON WITHOUT THE STENT MOVING WITH THE BALLOON HOWEVER, WITH MANIPULATION THE STENT BALLOON WAS SUCCESSFULLY REMOVED. THE STENT WAS PLACED AT THE LAD TO THE PROXIMAL FIRST DIAGONAL (D1) BRANCH. A 3.5 X 15 MM NC EUPHORA BALLOON WAS ADVANCED INSIDE THE STENT AND INFLATED AT 16ATM BUT ONLY STENTED THE PROXIMAL LAD TO THE OSTIAL D1. IT WAS UNABLE TO ADVANCE THROUGH UNDEPLOYED STENT PORTION IN THE PROXIMAL D1. A 2.5 X 12 MM NC EUPHORA BALLOON PASSED THROUGH THE UNDEPLOYED STENT PORTION IN T

  Patient problems: Insufficient Information

  MAUDE report 17711308 ↗
• InjuryJul 5, 2023Burst Container or Vessel; Entrapment of Device; Inflation Problem; Difficult to Remove; Detachment of Device or Device Component; Device Dislodged or Dislocated; Material Deformation; Material Split, Cut or Torn; Burst Container or Vessel; Entrapment of Device; Inflation Problem; Difficult to Remove; Detachment of Device or Device Component; Device Dislodged or Dislocated; Material Deformation; Material Split, Cut or Torn

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A SEVERELY CALCIFIED, NON-TORTUOUS LESION WITH 70% STENOSIS IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED NON-MEDTRONIC STENT, WHICH WAS IMPLANTED IN (B)(6) 2021. 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. IT WAS ALSO REPORTED THAT A BALLOON BURST, AND REMOVAL DIFFICULTIES OCCURRED. IT WAS DETAILED THAT IT WAS DECIDED TO REMOVE THE UNDEPLOYED ONYX FRONTIER STENT AS IT WAS TOO SHORT AND A LONGER STENT WAS INTENDED TO BE USED. UPON ATTEMPTED REMOVAL OF THE STENT DELIVERY SYSTEM RESISTANCE WAS FELT AT THE DISTAL LEFT MAIN/PROXIMAL LAD. THE STENT WAS STILL ON THE BALLOON, HOWEVER, IT FELT AS IF THE DEVICE WAS STUCK AT THE DISTAL LEFT MAIN/PROXIMAL LAD AND REMOVAL DIFFICULTIES OCCURRED. IT WAS DECIDED TO INFLATE THE BALLOON, HOWEVER, THE BALLOON WOULD NOT INFLATE, AND IT SEEMED TO HAVE BEEN RUPTURED. THE STENT DISL

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

  MAUDE report 17257192 ↗
• InjuryOct 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO ONYX FRONTIER DRUG ELUTING STENTS WERE IMPLANTED IN THE RCA. TWO LAUNCHER GUIDE CATHETERS WERE ALSO USED DURING THE PROCEDURE. DURING THE PROCEDURE THE PATIENT SUFFERED FROM A GRADE B DISSECTION IN THE RCA AFTER STENT IMPLANTATION. THE EVENT WAS TREATED WITH TWO ADDITIONAL ONYX FRONTIER STENTS. THE PATIENT RECOVERED. THE PRINCIPAL INVESTIGATOR BELIEVED THE DISSECTION WAS POSSIBLY CAUSED BY AN INJECTION THROUGH A NON MDT GUIDE CATHETER AND NOT CAUSED BY THE STENT OR MEDTRONIC DEVICES. HOWEVER IT WAS ALSO STATED THAT IT COULD NOT BE RULED OUT COMPLETELY THAT A MEDTRONIC DEVICE CAUSED THE DISSECTION.

  Patient problems: Vascular Dissection

  MAUDE report 15648340 ↗
• InjuryOct 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO ONYX FRONTIER DRUG ELUTING STENTS WERE IMPLANTED IN THE RCA. TWO LAUNCHER GUIDE CATHETERS WERE ALSO USED DURING THE PROCEDURE. DURING THE PROCEDURE THE PATIENT SUFFERED FROM A GRADE B DISSECTION IN THE RCA AFTER STENT IMPLANTATION. THE EVENT WAS TREATED WITH TWO ADDITIONAL ONYX FRONTIER STENTS. THE PATIENT RECOVERED. THE PRINCIPAL INVESTIGATOR BELIEVED THE DISSECTION WAS POSSIBLY CAUSED BY AN INJECTION THROUGH A NON MDT GUIDE CATHETER AND NOT CAUSED BY THE STENT OR MEDTRONIC DEVICES. HOWEVER IT WAS ALSO STATED THAT IT COULD NOT BE RULED OUT COMPLETELY THAT A MEDTRONIC DEVICE CAUSED THE DISSECTION.

  Patient problems: Vascular Dissection

  MAUDE report 15648226 ↗