Onyx Frontier™ ONYXNG27512UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00763000511371), received between Aug 2, 2023 and Nov 26, 2025 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2025Difficult to Advance; Device Dislodged or Dislocated; Material Deformation; Difficult to Advance; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT FELL OFF THE BALLOON. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE SHEATH WAS REMOVED PER IFU. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. IT WAS REPORTED THAT THE DEVICE WOULD NOT ADVANCE THROUGH THE NON-MEDTRONIC GUIDE EXTENSION CATHETER. THE DEVICE EXITED THE GUIDE EXTENSION CATHETER. THE DEVICE ENTERED THE PATIENT VASCULATURE. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE GUIDE EXTENSION CATHETER WAS EXAMINED AND FLUSHED BEFORE USE WITH NO ISSUES/KINKS NOTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23655014 ↗
• InjuryAug 13, 2025Device Damaged by Another Device; Device Dislodged or Dislocated; Material Deformation; Positioning Problem; Device Damaged by Another Device; Device Dislodged or Dislocated; Material Deformation; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE TWO ONYX FRONTIER CORONARY DRUG ELUTING STENTS DISLODGED DURING REMOVAL FOLLOWING A FAILED DELIVERY. THE LESION BEING TREATED WITH THE 2.75 X 26MM ONYX FRONTIER STENT WAS A NON TORTUOUS LESION WITH 95% STENOSIS IN THE PROXIMAL CIRCUMFLEX (LCX) ARTERY. THE LESION BEING TREATED WITH THE 2.75 X 12 MM ONYX FRONTIER STENT HAD 50% STENOSIS AND WAS LOCATED IN THE OSTIUM/PROXIMAL OBTUSE MARGINAL (OM). BOTH DEVICES WERE INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED ON THE 2.75 X 26MM ONYX FRONTIER STENT WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED ON THE 2.75X12MM ONYX FRONTIER STENT. BOTH LESIONS WERE PRE-DILATED. BOTH DEVICES PASSED THOUGH PREVIOUSLY DEPLOYED STENTS. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING BOTH DEVICES. PRE-STENT ANGIOPLASTY WAS PERFORMED IN THE LCX USING A NON-COMPLAINT NON-MEDTRONIC 2.75 X 12MM PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) BALLOON AT 14ATM. THE 2.75 X 26MM ONYX FRONTIER STENT WAS SUCCESSFULLY IMPLANTED IN THE LCX USING A JAILED BALLOON TECHNIQUE TO THE FIRST OBTUSE MARGINAL ARTERY (OM1) PATENCY AS SIDE BRANCH. A 2.5 X 20MM PTCA BALLOON WAS USED IN THE OM1 AND WAS INFLA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22791500 ↗
• MalfunctionMay 16, 2025Material Deformation; Material Deformation

  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 22034018 ↗
• InjuryJan 16, 2025Deformation Due to Compressive Stress; Device Dislodged or Dislocated; Positioning Problem; Deformation Due to Compressive Stress; Device Dislodged or Dislocated; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER DRUG-ELUTING STENT (DES) HOWEVER THE STENT FAILED TO CROSS THE LESION AND STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. THE LESION BEING TREATED WAS A MILDLY CALCIFIED, MILDLY TORTUOUS LESION IN THE PROXIMAL CIRCUMFLEX (CX) 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 NOTED WHEN ADVANCING THE DEVICE BUT EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE DISLODGED STENT WAS REMOVED FROM THE PATIENT.A NON-MEDTRONIC GUIDE EXTENSION CATHETER AND BALLOON WERE USED TO TRAP AND RETRIEVE THE STENT. IT WAS NOTED THAT THE LESION WAS PRE-DILATED AGAIN AFTER THE STENT DISLODGEMENT BEFORE A NON-MEDTRONIC DES WAS THEN DELIVERED TO TREAT THE LESION. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information

  MAUDE report 21166200 ↗
• MalfunctionOct 24, 2023Inflation Problem; Activation, Positioning or Separation Problem; Material Deformation; Inflation Problem; Activation, Positioning or Separation Problem; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT (DES) TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. IT WAS REPORTED THAT THE STENT WOULD NOT DEPLOY OFF THE CATHETER. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17993962 ↗
• InjuryAug 2, 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 CALCIFIED LESION WITH 80% STENOSIS. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT THE LESION. THE DISLODGED STENT WAS NOT REMOVED. THE DISLODGED STENT WAS CRUSHED IN THE ARTERY WALL WITH ANOTHER STENT. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

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

  MAUDE report 17441306 ↗