Onyx Frontier™ ONYXNG27526UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000511418), received between Aug 15, 2024 and May 6, 2026 — classified as 2 injuries, 2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2026Difficult to Insert; Difficult to Advance; Device Dislodged or Dislocated; Positioning Problem

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT WHEN THE STENT WAS UNABLE TO CROSS AND CAME OFF THE DELIVERY SYSTEM. A NON-MEDTRONIC GUIDEWIRE WAS USED AND THE LESION WAS BALLOONED, A NON-MEDTRONIC 2.75 X 28MM STENT WAS THEN ATTEMPTED TO BE USED AND COULD NOT CROSS THE LESION. A NON-MEDTRONIC GUIDE EXTENSION CATHETER (GEC) WAS THEN USED, HOWEVER THENON-MEDTRONIC STENT STILL COULD NOT CROSS. THE ONYX FRONTIER 2.75 X 26MM STENT WAS THEN ATTEMPTED TO BE USED. THERE WERE DIFFICULTIES NOTED WHEN ADVANCING THE STENT THROUGH THE GUIDEWIRE AND GEC AND WHEN THE GUIDE EQUIPMENT WAS REMOVED THE STENT WAS OFF THE BALLOON DELIVERY SYSTEM IN THE GUIDE. THE GUIDE WAS THEN REPLACED WITH A 6F LAUNCHER GUIDE CATHETER AND THE PROCEDURE WAS COMPLETED USING TWO ONYX FRONTIER DEVICES OF A DIFFERENT LOT NUMBERS. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS NOT INSPECTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION BEING TREATED WAS LOCATED IN THE PROXIMAL/MID RIGHT CORONARY ARTERY (RCA). THE LESION WAS MODERATELY TORTUOUS, MODERATELY CALCIFIED AND HAD 80% STENOSIS. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25095107 ↗
• InjuryAug 13, 2025Device Damaged by Another Device; Device Dislodged or Dislocated; Material Deformation; Device Damaged by Another Device; Device Dislodged or Dislocated; Material Deformation

  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 22791497 ↗
• MalfunctionSep 27, 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. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION. THE STENT FELL OFF THE BALLOON. THE DISLODGED STENT WAS REMOVED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20320728 ↗
• InjuryAug 15, 2024Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE 2.75 X 26 MM ONYX FRONTIER DRUG ELUTING STENT TO TREAT A MODERATELY CALCIFIED LESION IN THE OSTIUM OF THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 3.0 X 22MM ONYX FRONTIER STENT AND A 3.0 X 18MM ONYX FRONTIER STENT WERE ALSO ATTEMPTED TO BE USED DURING THE PROCEDURE TO TREAT A LESION. THE DEVICES WERE INSPECTED BEFORE USE WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE 3.0 X 22MM ONYX FRONTIER STENT AND A 3.0 X 18MM ONYX FRONTIER STENT WERE PREPPED PER IFU WITH NO ISSUES NOTED. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE 2.75 X 26 MM ONYX FRONTIER STENT AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE 2.75 X 26 MM ONYX FRONTIER STENT CAME OFF THE BALLOON DURING WITHDRAWAL OF THE DEVICE. THE STENT WAS BEING ATTEMPTED TO BE DEPLOYED BUT IT CAME OFF THE BALLOON AND HAD TO RETRIEVED OUT OF THE VESSEL BY SNARE. ONE 3.0 X 22MM ONYX FRONTIER STENT WAS ALSO REPORTED TO BE COMING OFF THE BALLOON BUT WAS ABLE TO BE SUCCESSFULLY DEPLOYED AND IMPLANTED IN THE PATIENT. INTRAVASCULAR LITHOTRIPSY (IVL) WAS PERFORMED FIRST, THEN THE STENT CAME OFF THE NON-MEDTRONIC WIR

  Patient problems: Insufficient Information; Vascular Dissection

  MAUDE report 19990973 ↗