Onyx Frontier™ ONYXNG30012UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00763000511463), received between Nov 1, 2022 and Apr 23, 2026 — classified as 10 injuries, 4 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 16, 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.

• MalfunctionApr 23, 2026Detachment of Device or Device Component; Device Dislodged or Dislocated

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT WHEN THE DEVICE OR DEVICE COMPONENT DET ACHED, CRACKED, OR FRACTURED. THE DETACHED PORTION OF THE DEVICE DOES NOT REMAIN IN THE PATIENT AND IT WAS NEVER IMPLANTED. THE DEVICE WAS NOT INSPECTED. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24962967 ↗
• InjuryMar 5, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT, STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT THE LESION. THE LESIONS BEING TREATED WERE MODERATELY CALCIFIED WITH 80% STENOSIS IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY AND 40% STENOSIS IN THE LM. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. WHEN ADVANCING THE STENT TO TREAT THE LESION IN THE LAD, THE STENT DISLODGED IN THE MID-DISTAL LEFT MAIN AND PROXIMAL LAD. THE STENT WAS THEN BALLOONED WITH AN NC EUPHORA BALLOON CATHETER. THE PATIENT WAS TRANSFERRED FOR EVALUATION AND TREATMENT, INCLUDING HIGH RISK PERCUTANEOUS CORONARY INTERVENTION AND POTENTIAL CORONARY ARTERY BYPASS GRAFT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24518775 ↗
• InjuryMar 5, 2026Device Damaged by Another Device; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT, STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT LESION LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED PRIOR TO USE AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE STENT DISLODGED AND CAME OFF THE BALLOON WHILE PASSING THROUGH A PREVIOUSLY DEPLOYED STENT. THE DISLODGED STENT WAS NOT REMOVED; INSTEAD, THE STENT WAS CRUSHED AGAINST THE VESSEL WALL. NO PROBLEMS WERE REPORTED AFTER THE STENT WAS CRUSHED. 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 24518027 ↗
• MalfunctionMay 16, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE THE CATHETER OF ONE 3.0X12MM ONYX FRONTIER CORONARY DRUG ELUTING STENT (DES) DETACHED, CRACKED OR FRACTURED DURING DELIVERY THROUGH THE VESSEL. THE DETACHED CATHETER WAS REMOVED FROM THE PATIENT. IT WAS ALSO REPORTED THAT ONE 2.75X12MM ONYX FRONTIER DES DEFORMED DURING POSITIONING/ADVANCEMENT. THE LESION BEING TREATED WAS MILDLY TORTUOUS, MODERATELY CALCIFIED AND LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. BOTH DEVICES WERE INSPECTED PRIOR TO USE WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED ON EITHER DEVICE. THE LESION WAS PRE-DILATED. RESISTANCE WAS ENCOUNTERED ADVANCING BOTH DEVICES, BUT EXCESSIVE FORCE WAS NOT USED. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22034017 ↗
• MalfunctionFeb 12, 2025Deformation Due to Compressive Stress; Detachment of Device or Device Component; Material Deformation; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE TWO ONYX FRONTIER CORONARY DRUG ELUTING STENTS WERE ATTEMPTED TO BE USED, AND ONE DEVICE COULD NOT BE ADVANCED OVER THE WIRE, WHILE THE OTHER DEVICE HAD A KINK IN THE CATHETER. THE DEVICES WERE BEING USED TO TREAT MODERATELY TORTUOUS, SEVERELY CALCIFIED LESIONS IN THE RIGHT CORONARY ARTERY (RCA) AND OBTUSE MARGINAL (OM). THE OM LESION WAS PRE-DILATED WITH A 2.5X15MM BALLOON. THE RCA WAS NOT PRE-DILATED. BOTH DEVICES WERE INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICES. EXCESSIVE FORCE WAS NOT USED. AN ATTEMPT WAS MADE TO DEPLOY THE 2.5X22MM ONYX FRONTIER STENT IN THE CALCIFIED RCA, BUT THE STENT WOULD NOT ADVANCE OVER THE NON-MEDTRONIC 0.014 190CM WIRE. IT WAS NOT DIFFICULT TO REMOVE THE PROTECTIVE SHEATH AND PACKAGING STYLETTE OF THE 2.5X22MM ONYX FRONTIER STENT. THE GUIDEWIRE LUMEN IN THE 2.5X22MM ONYX FRONTIER STENT DEVICE WAS FLUSHED BEFORE USE. THE GUIDEWIRE WAS EXAMINED AND FLUSHED BEFORE USE WITH NO ISSUES NOTED. THE GUIDEWIRE WAS BEING BACK LOADED THROUGH THE TIP. THE GUIDEWIRE HAD BEEN SUCCESSFULLY USED WITH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21364147 ↗
• MalfunctionJan 2, 2025Material Deformation; Positioning Problem; Material Deformation; Positioning Problem

  IT WAS REPORTED THAT DURING A CORONARY PROCEDURE INVOLVING AN ONYX FRONTIER CORONARY DRUG ELUTING STENT, THE STENT FAILED TO CROSS/POSITION. THE STENT WOULD NOT CROSS AND WHEN REMOVED FROM THE PATIENT, THE STENT HAD WAS DEFORMED. AN ATTEMPT WAS MADE TO USE A SECOND ONYX FRONTIER STENT OF THE SAME SIZE AND THIS STENT WOULD NOT CROSS THE LESION EITHER. THE FIRST ONYX FRONTIER STENT WAS INSPECTED WITH NO ISSUES NOTED AND RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21053146 ↗
• InjuryMay 10, 2024Device Dislodged or Dislocated; Positioning Problem; Device Dislodged or Dislocated; Positioning Problem

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT (DES) TO TREAT A SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 95% STENOSIS IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. 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 USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. THE STENT WAS DEPLOYED IN THE LAD WHERE IT EMBOLIZED. THE DISLODGED STENT WAS NOT REMOVED, SEMI COMPLIANT BALLOONS WERE USED 1.5MM, 2.0MM AND 3.0MM AND THEN A 3.5MM NON COMPLIANT (NC) BALLOON WAS USED TO POST DILATED THE STENT. THE TARGET LESION WAS THEN STENTED SUCCESSFULLY. IT WAS NOTED THAT THE PATIENT DID GREAT AND HAD A SUCCESSFUL OUTCOME. NO FURTHER PATIENT INJURY WAS REPORTED.

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

  MAUDE report 19293722 ↗
• InjuryMay 10, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER DRUG ELUTING STENT TO TREAT A LESION. IT WAS REPORTED THAT THE STENT CAME OFF THE DELIVERY SYSTEM INSIDE THE CATHETER. THERE WAS NO PATIENT INJURY REPORTED.

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

  MAUDE report 19285958 ↗
• InjurySep 25, 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 DURING AN INTRA-OPERATIVE PROCEDURE, STENT DISLODGEMENT AND STUCK IN THE PATIENT. IT WAS DETAILED THAT THE CARDIAC CATHETER PROCEDURE WAS CONDUCTED WITH FLUOROSCOPIC GUIDANCE. THE VESSEL WAS PRE-DILATED, AND A WIRE WAS ADVANCED TO THE OCCLUDED RIGHT CORONARY ARTERY. THE STENT ENTERED THE PROXIMAL VESSEL AND WOULD NOT PROCEED. THE STENT AND BALLOON WERE WITHDRAWN, HOWEVER THE STENT FAILED TO BE REMOVED, AND WAS STRIPPED OFF THE BALLOON IN THE VESSEL. THE PLACEMENT WAS CONFIRMED VIA IMAGING. AN EXHAUSTIVE ATTEMPT WAS MADE TO RECOVER THE STENT, BUT THIS WAS UNSUCCESSFUL. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND WAS ULTIMATELY TRANSFERRED TO ANOTHER FACILITY WHERE A DIFFERENT APPARATUS WAS AVAILABLE. THE PATIENT'S STATUS AT THE TIME OF THIS REPORT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17806243 ↗
• InjuryMay 26, 2023Difficult to Remove; Difficult to Advance; Device Dislodged or Dislocated; Positioning Problem; Difficult to Remove; Difficult to Advance; Device Dislodged or Dislocated; Positioning Problem

  A PATIENT PRESENTED WITH PROGRESSIVE DYSPNEA, SHORTNESS OF BREATH, CHEST PAIN AND POSSIBLE ANGINA. THE PATIENT UNDERWENT A CARDIAC PET SCAN THAT SHOWED SIGNIFICANT ISCHEMIA IN THE ANTERIOR ANTEROAPICAL TERRITORY WHICH WAS TREATED USING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA). AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER RX CORONARY DRUG ELUTING STENT TO TREAT A SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 99% STENOSIS IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. 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. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. IT WAS DETAILED THAT A 3.5 EBU GUIDE CATHETER AND A NON-MEDTRONIC WIRE WERE ADVANCED INTO THE DISTAL LAD. IT WAS NOTED AS BEING VERY DIFFICULT DUE TO THE SEVERE CALCIFICATION AND ALSO BECAUSE OF AN ANGULATED LESION AT PREVIOUSLY PLACED STENTS. A 2.0X12MM COMPLIANT BALLOON WAS BACKLOADED AND INFLATED SUCCESSFULLY. A 2.5X12MM NON-C OMPLIANT BAL

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

  MAUDE report 17010771 ↗
• InjuryApr 27, 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 SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 80% STENOSIS IN THE PROXIMAL 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. 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 A STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT THE LESION. STENT EMBOLIZATION WAS ALSO REPORTED. THE DISLODGED STENT WAS REMOVED USING A SNARE. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: Embolism/Embolus; Insufficient Information

  MAUDE report 16821798 ↗
• InjuryApr 26, 2023Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated; Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE 3.00 X 12MM ONYX FRONTIER DRUG ELUTING STENT (DES) TO TREAT A LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING THE DELIVERY. IT WAS REPORTED THAT A STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. IT WAS STATED THAT THE 3.00 X 12MM ONYX FRONTIER STENT WAS TOO SHORT AND WAS BEING REMOVED TO IMPLANT A LONGER LENGTH STENT. THE STENT BECAME DISLODGED WHEN IT WAS BEING PULLED BACK. THE DISLODGED STENT WENT INTO THE AORTA. THE DISLODGED STENT WAS NOT REMOVED AND INTERVENTION WAS CARRIED OUT. THE PATIENT IS ALIVE WITH NO INJURY.

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

  MAUDE report 16816364 ↗
• InjuryNov 7, 2022Malposition of Device; Device Dislodged or Dislocated; Material Deformation; Malposition of Device; Device Dislodged or Dislocated; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 90% STENOSIS. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION. IT WAS DETAILED THAT THE STENT WAS DELIVERED BEYOND THE LESION SITE AND AS THE STENT WAS PULLED INTO PLACE IT APPEARED THAT THE PROXIMAL EDGE OF THE DEVICE GOT CAUGHT ON THE STRUT OF THE PREVIOUSLY IMPLANTED STENT. THE PREVIOUSLY DEPLOYED STENT WAS DISTAL TO THE IDENTIFIED LESION. THE STENT DISTAL TO THE IDENTIFIED LESION HAD AN AREA IN THE PROXIMAL SEGMENT WHICH APPEARED TO BE UNDER-DEPLOYED. THE DISLODGED STENT WAS SUCCESSFULLY REMOVED WITH A SNARE. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15742503 ↗
• InjuryNov 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED LESION IN THE DISTAL CIRCUMFLEX (CX) ARTERY WITH 85% STENOSIS. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. 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 NO ALLEGED PRODUCT ISSUE OCCURRED HOWEVER IT WAS DETAILED THAT THE STENT WAS DEPLOYED IN THE DISTAL CIRCUMFLEX AND A PERFORATION WAS OBSERVED. A NON-MEDTRONIC STENT WAS DEPLOYED INSIDE OF THE ONYX TO SEAL OFF THE PERFORATION. NO FURTHER INJURY WAS REPORTED.

  Patient problems: Perforation

  MAUDE report 15706738 ↗