Onyx Frontier™ ONYXNG25012UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00763000511289), received between Sep 6, 2022 and Dec 22, 2025 — classified as 9 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (13 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryDec 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT, THE STENT DISLODGED IN VIVO DURING DELIVERY TO/AT LESION.  THE DISLODGED STENT WAS CRUSHED AGAINST THE VESSEL WALL AND REMAINS IN THE PATIENT. THE LESION BEING TREATED WAS A MILDLY TORTUOUS, MODERATELY CALCIFIED LESION IN THE MID CIRCUMFLEX (CX) ARTERY. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. 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 23861896 ↗
• MalfunctionOct 15, 2025Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT, A DETACHMENT OCCURRED IN VIVO. DURING REMOVAL OF THE DEVICE, THE DISTAL PORTION OF THE STENT DELIVERY SYSTEM BROKE OFF IN THE PATIENT'S VESSEL. THE PROXIMAL PART OF THE DELIVERY CATHETER WAS REMOVED, AND THE DISLODGED DISTAL PORTION OF THE DEVICE WAS SUBSEQUENTLY REMOVED FROM THE PATIENT VIA THE STOPCOCK. 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 23298133 ↗
• InjuryJul 28, 2025Device Damaged by Another Device; Device Dislodged or Dislocated; Device Damaged by Another Device; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A PROCEDURE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT DISLODGED DURING DELIVERY TO OR AT THE LESION. THE STENT BECAME CAUGHT ON A PRE-EXISTING STENT IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). AN ATTEMPT WERE MADE TO SNARE THE ONYX FRONTIER STENT BUT THE DISLODGED STENT WAS NOT REMOVED. THE DISLODGED ONYX FRONTIER STENT WAS SUBSEQUENTLY BALLOONED TO THE LEFT MAIN (LM) WALL. THE LESION BEING TREATED WAS MILDLY TORTUOUS, MILDLY CALCIFIED WITH 85% STENOSIS IN THE PROXIMAL LM ARTERY. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS NOT PRE-DILATED. THE DEVICE PASSED THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. NO FURTHER 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 22637516 ↗
• InjuryJul 28, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A PROCEDURE TWO ONYX FRONTIER CORONARY DRUG ELUTING STENTS DISLODGED DURING DELIVERY TO/AT THE LESION. THE LESION BEING TREATED WAS A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 95% STENOSIS LOCATED IN THE PROXIMAL LEFT MAIN (LM) CORONARY ARTERY/LEFT ANTERIOR DESCENDING (LAD) ARTERY. BOTH DEVICES WERE INSPECTED PRIOR TO USE AND NEGATIVE PREPPED WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE 2.50 X 12 MM ONYX FRONTIER STENT DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THIS DEVICE. IT WAS ATTEMPTED TO SNARE THE DISLODGED 2.75 X 22 MM ONYX FRONTIER STENT HOWEVER THIS WAS UNSUCCESSFUL. THE DISLODGED STENT WAS NOT REMOVED AND WAS THEN CRUSHED AND DEPLOYED IN THE VESSEL. THE DISLODGED 2.50 X 12 MM ONYX FRONTIER STENT WAS REMOVED USING A SNARE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22628514 ↗
• InjuryDec 11, 2024Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT DISLODGED DURING DELIVERY TO/AT THE LESION. THE STENT WAS UNABLE TO BE REMOVED FROM THE PATIENT AND ANOTHER STENT WAS USED TO PUSH THE DISLODGED STENT AGAINST THE VESSEL WALL. THE LESION BEING TREATED WAS SEVERELY CALCIFIED AND LOCATED IN THE RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE DEVICE. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

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

  MAUDE report 20900516 ↗
• InjurySep 17, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG-ELUTING STENT (DES) TO TREAT A LESION. WHILE ATTEMPTING TO DEPLOY THE STENT, THE STENT FLOATED OFF THE BALLOON AND WAS FREE FLOATING IN THE ARTERY. AN ATTEMPT WAS MADE TO SNARE OUT THE STENT BUT IT FAILED. THE FREE FLOATING STENT WAS INSTEAD MOVED INTO AN ALREADY EXISTING IMPLANTED DES. THE DISLODGED STENT WAS CRUSHED WITH ANOTHER DES TO PIN IT INTO THE ALREADY IMPLANTED STENT. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

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

  MAUDE report 20234982 ↗
• MalfunctionMay 7, 2024Difficult to Insert; Material Deformation; Difficult to Insert; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A LESION. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED. IT WAS STATED THAT THE STENT 'FELT FUNNY' WHEN MANEUVERING THROUGH THE GUIDE. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19258912 ↗
• MalfunctionJan 23, 2024Inflation Problem; Inflation Problem

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER DEVICE TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) LESION WAS PRE-DILATED 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. NEGATIVE PRESSURE WAS PULLED RIGHT BEFORE GOING UP. IT WAS REPORTED THAT THE BALLOON WOULD NOT INFLATE HOWEVER THE DIAL ON THE INFLATION DEVICE WENT UP TO 12, THIS WAS IDENTIFIED UNDER X-RAY. THE ENDOFLATOR WAS DISCONNECTED AND A NEW DEVICE WAS USED. THE STENT WAS DEPLOYED WITH NO ISSUES NOTED. LATER THE OLD ENDOFLATOR WAS TESTED ON A SPRINTER BALLOON THAT HAD BEEN USED AND IT RESPONDED JUST FINE. WHEN THE ENDOFLATOR WAS CONNECTED BACK WITH THE ONYX FRONTIER DEVICE IT REPEATED THE SAME ISSUE. THERE IS CONFUSION AS TO WHICH DEVICE IS AT FAULT, TOGETHER THEY DID NOT WORK TOGETHER. THE PATIENT IS ALIVE WITH NO ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18561690 ↗
• MalfunctionJan 5, 2024Inflation Problem; Activation, Positioning or Separation Problem; Device Dislodged or Dislocated; Inflation Problem; Activation, Positioning or Separation Problem; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A 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 NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT INFLATION DIFFICULTIES OCCURRED DURING BALLOON INFLATION. IT WAS DETAILED THAT THE STENT WAS INFLATED TO 10ATM AND ONLY THE DISTAL PORTION INFLATED. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18449951 ↗
• MalfunctionNov 23, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A LESION. IT WAS REPORTED THAT THE STENT CAME OFF OF THE BALLOON DURING DELIVERY THROUGH THE VESSEL. THE DISLODGED STENT AND BALLOON WERE RECOVERED. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18198078 ↗
• MalfunctionOct 9, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT (DES) TO TREAT A LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. IT WAS REPORTED THAT THE STENT WAS STRIPPED OFF THE BALLOON WHEN AN ATTEMPT WAS MADE TO RETRIEVE THE STENT FROM THE PATIENT. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17898348 ↗
• InjuryJul 5, 2023Inflation Problem; Activation, Positioning or Separation Problem; Device Damaged by Another Device; Device Dislodged or Dislocated; Inflation Problem; Activation, Positioning or Separation Problem; Device Damaged by Another Device; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED LESION WITH 75% STENOSIS 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 NOT 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 REMOVAL FOLLOWING A FAILED DELIVERY. THE STENT WAS DELIVERED TO THE LESION WITHOUT ANY ISSUE. HOWEVER, DURING DEPLOYMENT THE BALLOON WAS UNABLE TO HOLD PRESSURE AND THE STENT WAS PARTIALLY EXPANDED. THE STENT DELIVERY SYSTEM WAS ATTEMPTED TO BE REMOVED HOWEVER THE STENT GOT CAUGHT ON THE LAUNCHER GUIDE CATHETER. THE STENT DISLODGED FROM THE DELIVERY SYSTEM. A 1.2X8MM NON-MEDTRONIC DEVICE WAS THEN DELIVERED OVER THE WIRE THROUGH THE DISLODGED STENT AND WAS INFLATED DISTALLY IN AN ATTEMPT TO KEEP THE STENT ON THE WIRE DURING REMOVAL. THE DISLODGED STENT HOWEVER MOVED TO THE R SFA (RIGHT SUPERFICIAL FEMORAL ARTERY) DURING REMOVAL ATTEMPT. THE DISLODGED STENT WAS

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

  MAUDE report 17254516 ↗
• InjuryMar 13, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG-ELUTING STENT TO TREAT A MILDLY TORTUOUS, NON-CALCIFIED LESION IN THE OSTIUM OF THE RAMUS. 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. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT THE LESION. THE STENT WAS NOT REMOVED. THE STENT WAS CRUSHED AFTER IT DISLODGED. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 16528034 ↗
• InjuryJan 23, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 95% STENOSIS, IN THE OSTIUM CIRCUMFLEX (CX) 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 REMOVAL FOLLOWING FAILED DELIVERY. IT WAS DETAILED THAT THE STENT DISLODGED IN THE PATIENT'S LEFT MAIN AND LEFT ANTERIOR DESCENDING ARTERY. ATTEMPTS WERE MADE TO REMOVE THE STENT WITH BALLOONS AND A SNARE, HOWEVER, THIS WAS UNSUCCESSFUL. THE DISLODGED STENT WAS NOT REMOVED. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information

  MAUDE report 16222858 ↗
• InjuryNov 30, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER RX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION IN THE MID CIRCUMFLEX (CX) ARTERY. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING INSERTION INTO THE HOMEOSTATIC VALVE. THE STENT CAME OFF THE BALLOON IN THE LEFT MAIN ARTERY. THE PATIENT IS ALIVE WITH NO INJURY.

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

  MAUDE report 15885557 ↗
• MalfunctionNov 1, 2022Inflation Problem; Defective Device; Activation, Positioning or Separation Problem; Material Deformation; Inflation Problem; Defective Device; Activation, Positioning or Separation Problem; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A LESION. THE DEVICE WAS INSPECTED WITH ISSUES NOTED. THE DEVICE DID NOT 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 DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. STENT NON-DEPLOYMENT WAS ALSO REPORTED. INFLATION DIFFICULTIES WERE NOTED WHEREBY ABNORMAL RESISTANCE VIA THE INFLATOR WAS IDENTIFIED WHEN TRYING TO DEPLOY THE STENT INSIDE THE VESSEL. THE STENT APPEARED TO BE INTACT ON THE BALLOON AND WAS REMOVED FOR RE-PREPARATION. IT WAS STATED THAT ONE OF THE STRUTS ON THE STENT LOOKED DAMAGED. CONCERN WAS EXPRESSED AS TO HOW IT WOULD FULLY DEPLOY. THE PROCEDURE WAS COMPLETED BY USING A 2.5 X 12MM STENT. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15708201 ↗
• MalfunctionSep 6, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER DRUG ELUTING STENT (DES) TO TREAT A NON TORTUOUS NON CALCIFIED LESION WITH 80% STENOSIS IN THE MID SAPHENOUS VEIN GRAFT (SVG). THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, HOWEVER EXCESSIVE FORCE WAS NOT USED DURING THE DELIVERY OF THE DEVICE. IT WAS REPORTED THAT THE DEVICE FAILED TO CROSS THE LESION. THE LESION APPEARED TO BE WHERE THE CLIPS WERE ATTACHED ON THE VEIN GRAFT. WHEN THE STENT WAS ATTEMPTED TO BE REMOVED IT CAUGHT ON THE GUIDER. THE STENT WAS THEN CAUGHT ON THE CATHETER. SEVERAL ATTEMPTS WERE MADE TO FREE THE STENT FROM THE GUIDER. THE GUIDER, STENT AND WIRE WERE REMOVED ALL AT ONCE. ONCE REMOVED IT WAS SEEN THAT THE STENT WAS SLIGHTLY DISLODGED FRO M THE DELIVERY CATHETER. ANOTHER ONYX FRONTIER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT IS REPORTED TO BE ALIVE WITH NOINJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15360379 ↗