Onyx Frontier™ ONYXNG22515UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00763000511203), received between Mar 6, 2023 and Apr 8, 2026 — classified as 6 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (8 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.

• MalfunctionApr 8, 2026Material Deformation; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT, POSITIONING DIFFICULTIES WERE ENCOUNTERED AND THE STENT BECAME DEFORMED DURING POSITIONING. AN ATTEMPT WAS MADE TO ADVANCE AND POSITION THE STENT IN THE LEFT ANTERIOR DESCENDING ARTERY, BUT THE STENT WOULD NOT GO INSIDE THE VESSEL AND RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE STENT WAS REMOVED AND WAS FOUND TO BE DAMAGED. THE LESION IN THE LEFT ANTERIOR DESCENDING ARTERY WAS THEN TREATED SUCCESSFULLY USING A DIFFERENT STENT (2.25 × 12MM) WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24814393 ↗
• InjuryOct 20, 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, STENT DISLODGEMENT OCCURRED DURING REMOVAL AFTER A FAILED DELIVERY. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX (CX) ARTERY AT THE OSTIUM WHICH EXHIBITED MODERATETORTUOSITY AND MODERATE CALCIFICATION. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND NO EXCESSIVE FORCE WAS USED. THE DISLODGED STENT WAS SURGICALLY REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23337709 ↗
• MalfunctionJun 17, 2025Deformation Due to Compressive Stress; Material Deformation; Positioning Problem; Deformation Due to Compressive Stress; Material Deformation; Positioning Problem

  IT WAS REPORTED THAT ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT WAS INSERTED INTO THE CALCIFIED DISTAL CIRCUMFLEX (CX) LESION BUT FAILED TO CROSS AND DAMAGE/DEFORMATION WAS NOTED TO THE TIP OF THE STENT WHEN IT WAS REMOVED. A SHOCKWAVE BALLOON WAS USED. THE DEVICE WAS REPLACED WITH ANOTHER SAME SIZE ONYX FRONTIER STENT WHICH WAS SUCCESSFULLY USED. THE PATIENT IS REPORTED TO BE FINE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22217814 ↗
• InjuryJul 3, 2024Activation, Positioning or Separation Problem; Device Damaged by Another Device; Material Deformation; Activation, Positioning or Separation Problem; Device Damaged by Another Device; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG-ELUTING STENT TO TREAT A LESION IN THE MID RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUE NOTED. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOTED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO POST-DEPLOYMENT. IT WAS STATED THAT THE STENT WAS DEPLOYED IN THE RCA VESSEL, BUT THE WIRE PLACEMENT WAS LOST. WHEN TRYING TO RE-WIRE TO POST-DILATE THE STENT WITH A BALLOON, THE STENT STRUTS WERE PULLED/UNRAVELED DUE TO THE WIRE KNUCKLE. IT WAS NOTED THAT THE PROXIMAL PART OF THE STENT WAS DISTORTED, AND IT WAS PLANNED TO DO ANOTHER PROCEDURE ON THE PATIENT 2 DAYS LATER TO OPEN OR CRUSH THE STENT AGAINST THE VESSEL WALL. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information

  MAUDE report 19665151 ↗
• InjuryMar 26, 2024Premature Activation; Device Dislodged or Dislocated; Premature Activation; 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 SELF DEPLOYED. THE STENT HAD TO BE CRUSHED. NO FURTHER PATIENT INJURY REPORTED.

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

  MAUDE report 18978710 ↗
• MalfunctionDec 18, 2023Device Dislodged or Dislocated; Material Deformation; Positioning Problem; Device Dislodged or Dislocated; Material Deformation; Positioning Problem

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 99% STENOSIS IN THE OSTIUM OF THE RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS NOT INSPECTED. 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 USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. THE DISLODGED STENT WAS REMOVED. THE DISLODGED STENT WAS CAUGHT ON A NON-MEDTRONIC GUIDE EXTENSION CATHETER AND REMOVED. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18351438 ↗
• InjuryDec 8, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER DRUG ELUTING STENT (DES) TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION WITH 95% STENOSIS IN THE OSTIUM IN THE 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 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. THE DISLODGED STENT WAS NOT REMOVED. THE DISLODGED STENT WAS CRUSHED AGAINST THE VESSEL WALL. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

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

  MAUDE report 18297028 ↗
• InjuryNov 18, 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 MILDLY TORTUOUS, SEVERELY CALCIFIED LESION 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 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 LESION. THE DISLODGED STENT WAS NOT REMOVED. THE DISLODGED STENT WAS BALLOONED IN PLACE WITH A SEPARATE BALLOON. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

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

  MAUDE report 18166768 ↗
• MalfunctionAug 15, 2023Device Dislodged or Dislocated; Material Deformation; Positioning Problem; Device Dislodged or Dislocated; Material Deformation; Positioning Problem

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION WITH 95% STENOSIS IN THE PROXIMAL RIGHT POSTERIOR DESCENDING (R-PDA) ARTERY. 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 ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS USED DURING DELIVERY. IT WAS REPORTED THAT THE STENT FAILED TO CROSS THE LESION. IT WAS DETAILED THAT DIRECT STENTING WAS ATTEMPTED HOWEVER, THE STENT DID NOT CROSS THE LESION. UPON RETRIEVAL OF THE STENT FROM THE VESSEL, THE PROXIMAL STENT STRUTS WERE DISRUPTED OR LIFTED ON THE DELIVERY SYSTEM. THE STENT WAS SUCCESSFULLY RETRIEVED BY REMOVING THE GUIDE AND THE STENT FROM THE VESSEL OUT OF THE BODY THROUGH THE 6F SHEATH. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17552173 ↗
• InjuryAug 1, 2023Difficult to Insert; Device Damaged by Another Device; Device Dislodged or Dislocated; Difficult to Insert; 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 MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION WITH 70% STENOSIS IN THE MID/DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS NOT PRE-DILATED. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED DURING DELIVERY TO/AT THE LESION. IT WAS ALSO REPORTED THAT POOR GUIDEWIRE MOVEMENT ISSUES WERE ENCOUNTERED. IT WAS DETAILED THAT A NON-MEDTRONIC STENT WAS IMPLANTED IN THE PROXIMAL LAD AND AFTER STENT DEPLOYMENT A DISTAL EDGE DISSECTION WAS NOTED. THE ONYX FRONTIER STENT WAS USED TO COVER THE DISSECTION. THE ONYX FRONTIER STENT BECAME TANGLED WITH THE NON-MEDTRONIC STENT WHICH CAUSED THE ONYX FRONTIER STENT TO DISLODGE FROM THE DELIVERY SYSTEM. THE DISLODGED STENT WAS NOT REMOVED. IT WAS DETAILED THAT THE ONYX FRONTIER WAS SMASHED DOWN IN PLACE WITH A BALLOON, AND THE PROCEDURE WAS COMPLETED. THE PATIENT WAS DISCHARGED THE NEXT DAY. NO FURTHER PATIENT INJURY WAS

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

  MAUDE report 17435865 ↗
• MalfunctionApr 6, 2023Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT AND ONE INTEGRITY RX CORONARY STENT TO TREAT A SEVERELY CALCIFIED LESION. THE ONYX FRONTIER 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 USED DURING DELIVERY. THERE WAS NO DAMAGE NOTED TO THE INTEGRITY RX STENT PACKAGING. THERE WERE ISSUES NOTED WHEN REMOVING THE INTEGRITY RX FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED WITH ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED.  IT WAS REPORTED THAT DURING INSPECTION OF THE DEVICE THE STENT WAS NOT ON THE BALLOON AND STENT DISLODGEMENT OCCURRED DURING SHEATH REMOVAL. THE INTEGRITY RX STENT WAS NOT USED IN THE PATIENT. IT WAS REPORTED THAT THE ONYX FRONTIER STENT DEFORMED IN VIVO DURING POSITIONING/ADVANCEMENT. IT WAS DETAILED THAT A SAME SIZE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16688279 ↗
• MalfunctionMar 6, 2023Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG-ELUTING STENT TO TREAT A LESION. 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 DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. THE PROCEDURE WAS COMPLETED WITH A NON-MEDTRONIC DEVICE OF THE SAME SIZE. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16485471 ↗