Onyx Frontier™ ONYXNG30034UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00763000511524), received between Mar 13, 2023 and May 15, 2026 — classified as 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2026Device Damaged by Another Device; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT, STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. THE STENT STRUT GOT CAUGHT ON THE GUIDE CATHETER WHEN TRYING TO DELIVER THE STENT TO THE LESION. THE STENT WAS REMOVED SUCCESSFULLY FROM THE GUIDE CATHETER. THE LESION BEING TREATED WAS NON-TORTUOUS AND LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. THERE WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE BUT EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE DEVICE WAS REPLACED WITH ANOTHER MEDTRONIC 3.0X34MM STENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25182085 ↗
• InjuryJan 9, 2026Deflation Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT, DEFLATION DIFFICULTIES WERE ENCOUNTERED, POST STENT DEPLOYMENT. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE DEVICE WOULD NOT DEFLATE AT THE LESION SITE LOCATED IN THE LEFT MAIN (LM) ARTERY. IT WAS REPORTED THAT ONCE THE STENT WAS DEPLOYED, THE STENT BALLOON WOULD NOT DEFLATE. IT WAS UNKNOWN IF IT WAS AN INDEFLATOR ISSUE OR A STENT BALLOON ISSUE. IT WAS REPORTED THAT THE OPERATOR TRIED TO USE A SYRINGE TO DEFLATE THE BALLOON. THE STENT BALLOON, GUIDEWIRE AND GUIDE ALL HAD TO BE REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24021315 ↗
• InjuryNov 13, 2025Difficult to Remove; Device Dislodged or Dislocated; Positioning Problem; Difficult to Remove; Device Dislodged or Dislocated; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT DISLODGED DURING REMOVAL FOLLOWING A FAILED DELIVERY. THE LESION BEING TREATED WAS MILDLY TORTUOUS, SEVERELY CALCIFIED IN THE OSTIUM OF THE LEFT MAIN (LM) CORONARY ARTERY. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. A 3.0 X 25MM EUPHORA BALLOON CATHETER WAS PLACED ACROSS THE LESION AND GIVEN A SINGLE INFLATION WITH A MAXIMUM INFLATION PRESSURE OF 14 ATM. SUCCESSFUL BALLOON ANGIOPLASTY WAS PERFORMED. AN ATTEMPT WAS MADE TO DELIVER THE 3.0 X 34MM ONYX FRONTIER STENT BUT THE DEVICE COULD NOT CROSS THE LESION. STENT DISLODGEMENT OCCURRED DURING REMOVAL. THE STENT CAME OFF THE BALLOON PARTIALLY IN THE LM AND PARTIALLY IN THE AORTA LIKELY DUE TO LM CALCIUM/STENT. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO REMOVE THE STENT WITH MULTIPLE APPROACHES/TECHNIQUES INCLUDING MULTIPLE SNARES BUT WERE UNSUCCESSFUL. THE STENT REMAINED IN THE PATIENT WITH THE DISTAL END LODGED IN THE

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 23543029 ↗
• MalfunctionFeb 20, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ONE ONYX FRONTIER DRUG ELUTING CORONARY STENT DISLODGED DURING SHEATH REMOVAL. DURING SHEATH REMOVAL THE STENT CAME OFF WITH THE STYLET. THE STENT AND STYLET WERE PLACED ON THE TABLE; HOWEVER, THE STENT BALLOON DELIVERY SYSTEM WAS DELIVERED INTO PATIENT'S BODY. THERE WAS NO DAMAGE NOTED TO THE PACKAGING, AND THERE WERE NO ISSUES NOTED REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED PRIOR TO USE WITH ISSUES NOTED. THE LESION BEING TREATED WAS IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) AND HAD 80% STENOSIS. 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. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21419814 ↗
• InjuryFeb 12, 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 FOLLOWING A FAILED DELIVERY. THE LESION BEING TREATED WAS MILDLY TORTUOUS, SEVERELY CALCIFIED IN THE PROXIMAL LEFT MAIN (LM) CORONARY ARTERY AND THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS DETAILED THAT A SNARE WAS SUCCESSFULLY USED TO REMOVE THE DISLODGED STENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Low Pulmonary Arterial Wedge Pressure

  MAUDE report 21362362 ↗
• InjuryJun 19, 2024Defective Component; Defective Component

  AN ATTEMPT WAS MADE TO USE ONE 3.0 X 34MM ONYX FRONTIER DRUG ELUTING STENT TO TREAT A LESION. IT WAS STATED THAT 3.0 X 34MM WAS INDICATED ON THE BOX, PACKAGE AND STENT DELIVERY DEVICE HUB. IT WAS REPORTED THAT WHEN THE STENT BALLOON WAS INFLATED TO 14 ATM FOR 21 SECONDS, THE BALLOON APPEARED LARGER THAN THE EXPECTED 3.0MM. INTRAVASCULAR ULTRASOUND MEASURED THE BALLOON EXPANDED STENT AT 3.5 MM. A DISTAL STENT EDGE DISSECTION WAS ALSO NOTED WHICH REQUIRED ADDITION STENTING. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Insufficient Information; Vascular Dissection

  MAUDE report 19566552 ↗
• MalfunctionFeb 12, 2024Difficult to Insert; Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material; Device Dislodged or Dislocated; Material Deformation; Difficult to Insert; Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material; Device Dislodged or Dislocated; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, MILDLY CALCIFIED LESION WITH 100% CHRONIC TOTAL OCCLUSION (CTO) IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS NOT INSPECTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PREDILATED. 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. IT WAS DETAILED THAT DURING DELIVERY OF THE STENT RESISTANCE WAS FELT WITHIN THE GUIDE CATHETER AS THE STENT ADVANCED PAST THE TRAPPER BALLOON. A SECOND WIRE THAT WAS IN THE DIAGONAL BRANCH WAS PULLED OUT. THE ONYX FRONTIER STENT WAS THEN REMOVED AND AS THE STENT WAS REMOVED BACK THROUGH THE GUIDE CATHETER AND THE HEMOSTATIC VALVE IT WAS NOTICED THAT THE STENT HAD DISLODGED FROM THE STENT DELIVERY SYSTEM (SDS) AND THE STENT HAD UNRAVELED. THE DEVICE WAS NOT KINKED AND RE-STRAIGHTENED DURING USE. THE DISLODGED STENT WAS REMOVED FROM THE GUIDE CATHETER AS IT WAS NEVER DELIVERED INTO THE CORONARY ARTERY. IT WAS ALSO STATED THAT THE DEVICE OR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18685805 ↗
• InjuryJan 26, 2024Burst Container or Vessel; Inflation Problem; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Material Deformation; Burst Container or Vessel; Inflation Problem; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Material Deformation

  AN ATTEMPT WAS MADE TO USE AN ONYX FRONTIER DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION WITH 95% STENOSIS IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT INFLATION DIFFICULTIES AND A BALLOON BURST OCCURRED DURING BALLOON INFLATION. THE BALLOON WAS INFLATED THREE TIMES TO 18, 20, AND 24 ATM PRIOR TO THE BALLOON BUST. INFLATION DIFFICULTIES WERE ENCOUNTERED WHEN THE BALLOON WAS INFLATED TO 24 ATM, AND THE BURST OCCURRED ON THE THIRD INFLATION AT 24 ATM. REMNANTS OF BALLOON MATERIAL REMAINED IN SOFT TISSUE AFTER THE STENT BALLOON RUPTURED. THE FOREIGN BODY WAS REMOVED UNDER LOCAL ANESTHESIA AND CONSCIOUS SEDATION BY A SURGEON. A PIECE OF THE BALLOON WAS REMOVED FROM THE SOFT TISSUE, AND THE DISTAL END WAS FRAYED. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information

  MAUDE report 18586927 ↗
• InjuryMar 13, 2023Difficult to Remove; Device Dislodged or Dislocated; Material Deformation; Difficult to Remove; Device Dislodged or Dislocated; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT (DES) TO TREAT A SEVERE CALCIFIED, MILD TORTUOUS LESION WITH 90% STENOSIS LESION IN THE PROXIMAL/MID/DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PATIENT HAD A SACCULAR ANEURYSM IN THE MID LAD. THE DEVICE WAS INSPECTED WITH NO ISSUES WERE. 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. A RIGHT FEMORAL APPROACH WAS USED. IT WAS REPORTED THAT STENT DEFORMATION AND STENT DISLODGEMENT OCCURRED WHEN AN ATTEMPT WAS MADE TO REMOVE THE UNDEPLOYED STENT FOLLOWING FAILED DELIVERY. IT WAS DETAILED THAT A NON-MEDTRONIC (MDT) GUIDEWIRE WAS INSERTED THROUGH THE LESION AND CHANGED TO ANOTHER NON-MDT WIRE OVER A NON-MDT CATHETER. ROTATIONAL ATHERECTOMY WAS PERFORMED. POST-ATHERECTOMY WIRE WAS EXCHANGED FOR A NON-MDT WIRE. THE DISTAL LAD WAS TREATED WITH A 3.0 X 38MM ONYX FRONTIER DES. THEN THE 3.0 X 34MM ONYX FRONTIER DES WAS DELIVERED DOWN THE MID LAD, HOWEVER, IT BECAME STUCK IN THE PROXIMAL SEGMENT AND DISLODGED FROM THE BALLOON. RESISTANCE WAS NOTED DURING ATTEMPTED WITHDRAWAL OF THE DEVICE

  Patient problems: Insufficient Information

  MAUDE report 16527972 ↗