Onyx Frontier™ ONYXNG22512UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00763000511197), received between Dec 5, 2022 and Dec 19, 2025 — classified as 9 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (10 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.

• InjuryDec 19, 2025Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT, THE STENT DISLODGED IN VIVO DURING DELIVERY THROUGH THE VESSEL. THE DISLODGED STENT WAS RETRIEVED FROM THE PATIENT USING A SNARE. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE DEVICE WAS NOT KINKED AND RESTRAIGHTENED DURING USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23847536 ↗
• InjuryNov 28, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT, STENT DISLODGEMENT OCCURRED IN VIVO. THE STENT CAME OFF THE STENT CATHETER WHEN IT WAS CAUGHT ON A CALCIUM DEPOSIT IN THE VESSEL. DUE TO THE FLOATING STENT, THE STENT WAS CRUSHED AGAINST THE WALL OF THE ARTERY AND WAS CONSIDERED AN UNINTENDED ITEM LEFT IN THE BODY. NO FURTHER PATIENT COMPLICATIONSHAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 23671025 ↗
• InjuryNov 4, 2024Device Dislodged or Dislocated; Positioning Problem; Device Dislodged or Dislocated; Positioning Problem

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION LOCATED IN THE CIRCUMFLEX (CX) ARTERY / OBTUSE MARGINAL (OM). 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 THE STENT FAILED TO CROSS THE LESION AND DISLODGED. IT WAS STATED THAT THE STENT WAS ADVANCED TO THE CIRCUMFLEX AND THE 1ST OM WAS THE TARGET LESION BUT THE STENT DID NOT CROSS. THE DEVICE WAS REMOVED. A 6F TELESCOPE CATHETER WAS INSERTED AND THE ORIGINAL STENT CATHETER WAS GOING TO BE RE-INSERTED BUT IT WAS DISCOVERED THAT THE STENT WAS NO LONGER ON THE BALLOON. THE LOCATION OF THE UNDEPLOYED STENT WAS IN THE CIRCUMFLEX ARTERY. A WIRE WAS INSERTED PASSED DISLODGED, UNDEPLOYED STENT IN THE CIRCUMFLEX ARTERY. A 2.0X15 MM BALLOON WAS ADVANCED TO THE UNDEPLOYED STENT AND INFLATED. THE BALLOON CATHETER WAS REMOVED. ANOTHER ONYX FRONTIER STENT (ONYXNG22512UX , LOT NUMBER

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

  MAUDE report 20596932 ↗
• InjuryJun 6, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A LESION IN THE PROXIMAL LEFT MAIN (LM) CORONARY ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION. THE DISLODGED STENT WAS REMOVED USING A SNARE. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information

  MAUDE report 19476225 ↗
• MalfunctionOct 26, 2023Device Damaged by Another Device; Device Damaged by Another Device

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT (DES) TO TREAT A MODERATELY TORTUOUS LESION IN THE LEFT MAIN (LM) CORONARY ARTERY. 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.EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT THE LESION. IT WAS LATER REPORTED THAT THE ONYX FRONTIER STENT WAS PASSING THROUGH TWO FRESHLY DEPLOYED ONYX FRONTIER STENTS IN THE OSTIAL LEFT ANTERIOR DESCENDING (LAD) (ONYXNG25018UX ¿ PLI20) AND THE OSTIAL HIGH DIAGONAL (ONYXNG22512UX ¿ PLI30) WHEN THE STENT STRIPPED OFF. THE ONYX FRONTIER STENT IN THE OSTIAL LEFT ANTERIOR DESCENDING (LAD) HAD BEEN DEPLOYED USING A MINICRASH TECHNIQUE. IT WAS REPORTED TH AT THE 2.25X18MM ONYX FRONTIER STENT (PLI10) GOT HUNG UP TRYING TO PASS THE DEPLOYED STENTS. IT IS UNCLEAR OF THE EXTENT OF THE ROLE OF THE PREVIOUSLY PLACED STENTS. IT WAS REPORTED THAT THE 2.25X18MM ONYX FRONTIER STENT (PLI10) WAS STRIPPED OFF THE BALLOON WHEN AN ATTEMPT WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18009544 ↗
• MalfunctionOct 3, 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 TO TREAT A LESION IN THE DISTAL 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. EXCESSIVE FORCE WAS NOT USED DURING THE DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. IT WAS DETAILED THAT A 6F LAUNCHER GUIDE CATHETER, A NON-MEDTRONIC GUIDE WIRE AND A 2.50X15MM EUPHORA BALLOON WERE USED IN THE DISTAL RCA. AN ATTEMPT WAS MADE TO DELIVER A NON-MEDTRONIC STENT BUT IT WOULD NOT CROSS THE LESION. THE ONYX FRONTIER STENT WAS THEN ATTEMPTED TO BE DELIVERED HOWEVER, IT TOO FAILED TO CROSS THE LESION. IT WAS DETAILED THAT WHEN REMOVING THE UNDEPLOYED STENT, IT SHEARED OFF THE BALLOON WHILE THE CATHETER WAS COMING OUT OF THE BODY. THE DISLODGED STENT WAS REMOVED USING THE GUIDE CATHETER. THE DISLODGED STENT WAS RETRIEVED WITH NO HARM TO THE PATIENT. THE PATIENT IS ALIVE WITH INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17864842 ↗
• MalfunctionSep 21, 2023Material Deformation; Positioning Problem; Material Deformation; Positioning Problem

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER DRUG ELUTING STENT (DES) TO TREAT A LESION LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. IT WAS ATTEMPTED TO ADVANCE THE STENT OVER THE WIRE PAST THE LESION HOWEVER IT FAILED TO CROSS THE LESION. THE STENT WAS THEN REMOVED AND IT WAS NOTED THAT THE STENT WAS DEFORMED DURING THE POSITIONING/ADVANCEMENT OF THE STENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17787133 ↗
• InjuryJul 28, 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 TO TREAT A SEVERELY TORTUOUS, MILDLY CALCIFIED LESION WITH 85% STENOSIS IN THE MID CIRCUMFLEX (CX) ARTERY. THE LEFT MAIN (LM) IS LONG WITH A SIGNIFICANT 130-DEGREE BEND OF THE CX OFF THE LM. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS SUCCESSFULLY PRE-DILATED WITH A 2.0 X 15MM BALLOON. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. IT WAS DETAILED THAT A 2.0 X 22MM ONYX FRONTIER STENT WAS SUCCESSFULLY PLACED IN THE MID CX. WHEN ATTEMPTING AN INTRAVASCULAR ULTRASOUND (IVUS) THE IMAGING CATHETER WOULD NOT ADVANCE INTO THE CX. A POSSIBLE PROXIMAL STENT EDGE DISSECTION WAS OBSERVED. THE 2.25 X 12MM ONYX FRONTIER STENT WAS ATTEMPTED TO BE PLACED IN THE PROXIMAL CX TO OVERLAP THE 2.0 X 22MM ONYX FRONTIER STENT THAT WAS IMPLANTED. HOWEVER , THE 2.25 X 12MM ONYX FRONTIER STENT COULD NOT BE DELIVER TO THE INTENDED AREA AS THE DELIVERY SYSTEM STOPPED AS IT WAS TURNING INTO THE PROXIMAL CX

  Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information; Obstruction/Occlusion; Vascular Dissection

  MAUDE report 17412345 ↗
• InjuryMay 9, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER DRUG ELUTING STENT (DES) TO TREAT A SEVERELY TORTUOUS, MILDLY CALCIFIED LESION IN THE MID OBTUSE MARGINAL (OM) ARTERY. 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. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING THE DELIVERY. IT WAS REPORTED THAT A STENT DISLODGEMENT OCCURRED DURING THE DELIVERY TO/AT THE LESION. THE DISLODGED STENT WAS NOT REMOVED. THE DISLODGED STENT WAS IMPLANTED UNDEPLOYED AGAINST THE CIRCUMFLEX (CX) ARTERY WALL BY ANOTHER DES STENT. IT WAS DETAILED THAT THE STENT DOTTER TECHNIQUE WAS USED AS WELL. ALSO A 6FR TELESCOPE WAS USED. THE PATIENT WAS FINE WITH NO INJURIES POST PROCEDURE.

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

  MAUDE report 16893887 ↗
• InjuryApr 26, 2023Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY CALCIFIED, SEVERELY TORTUOUS LESION IN THE MID RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. AN ATTEMPT WAS MADE TO DELIVER THE STENT TO THE POSTEROLATERAL ARTERY (PLA). THE STENT DIDN¿T DELIVER AND A DECISION WAS MADE TO REMOVE THE STENT. THE CATHETER DELIVERY SYSTEM WAS REMOVED, AND IT WAS THEN DECIDED TO STENT THE PROXIMAL RCA. USING FLUOROSCOPY IT WAS REALIZED THE STENT FROM THE ATTEMPTED PLA DELIVERY WAS IN THE BODY AND HAD BEEN STRIPPED OFF. THE DISLODGED STENT COULD NOT BE REMOVED AS IT WAS MADE MORE DIFFICULT TO TRY AND REMOVE THE STENT THROUGH THE FRESHLY IMPLANTED PROXIMAL RCA STENT. THE WIRE WAS STILL THROUGH THE DISLODGED STENT AND THE STENT WAS PULLED BACK USING A BALLOON. THE DISLODGED STENT WAS DEPLOYED IN THE MID RCA, DISTAL TO THE NEWLY IMPLANTED PROXIMAL RCA ST ENT. DURING

  Patient problems: Insufficient Information; Vascular Dissection

  MAUDE report 16813966 ↗
• InjuryMar 8, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 85% STENOSIS IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT THE STENT FAILED TO CROSS THE LESION. IT WAS DETAILED A CSI HAD BEEN DONE AND ALSO HAD GUIDELINES INSERTED. UPON REMOVAL OF THE CATHETER, THE STENT DISLODGED IN THE LAD. THE STENT WAS NOT REMOVED. IT WAS CRUSHED AGAINST THE ARTERY WALL. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: Insufficient Information

  MAUDE report 16503480 ↗
• InjuryDec 5, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER DRUG ELUTING STENT TO TREAT A SEVERLY CALCIFIED LESION WITH 80% STENOSIS IN THE DISTAL OBTUSE MARGINAL (OM). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED, THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE HOWEVER EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT LESION. THE DISLODGED STENT WAS NOT REMOVED. IT WAS STATED THAT WIRE PLACEMENT WAS LOST. THE FAMILY WERE SPOKEN TO WITH RESPECT TO SURGERY OPTIONS. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

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

  MAUDE report 15914769 ↗