Onyx Frontier™ ONYXNG35034UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000511616), received between Aug 3, 2023 and Aug 20, 2025 — classified as 1 injury, 4 malfunctions.

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

• InjuryAug 20, 2025Inflation Problem; Difficult to Insert; Leak/Splash; Difficult to Remove; Deformation Due to Compressive Stress; Material Deformation; Inflation Problem; Difficult to Insert; Leak/Splash; Difficult to Remove; Deformation Due to Compressive Stress; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG-ELUTING STENT, INSERTION DIFFICULTIES WERE ENCOUNTERED. RESISTANCE WAS NOTED WHEN IT WAS ATTEMPTED TO ADVANCE THE STENT THROUGH THE NON-MEDTRONIC HEMOSTASIS VALVE. THE STENT DELIVERY SYSTEM WAS REMOVED FROM THE GUIDEWIRE FOR INSPECTION. NO ISSUES WERE NOTED AND THE STENT WAS RE-INSERTED WITHOUT ISSUE. THE LESION BEING TREATED WAS MILDLY TORTUOUS AND SEVERELY CALCIFIED LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 95% STENOSIS. THE LESION WAS PRE-DILATED. THE STENT DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED ADVANCING THE STENT. NO EXCESSIVE FORCE WAS USED DURING DELIVERY. THE STENT WAS INSPECTED PRIOR TO USE AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE STENT WAS DELIVERED TO THE LESION WITHOUT RESISTANCE. UPON INFLATING THE STENT BALLOON AT 14ATM, IT WAS NOTED THAT ONLY THE DISTAL ENDS OF THE STENT BALLOON APPEARED TO INFLATE. A LITTLE DOG BONING WAS NOTICED AT THE ENDS OF THE STENT BALLOON. BLOOD CAME BACK INTO THE SYRINGE WHEN NEGATIVE WAS PULLED. IT APPEARED THAT A STENT BALLOON LEAK OCCURRED. THE PHYSICIAN PULLED NEGATIVE AGAIN AND RE-AT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22848989 ↗
• MalfunctionDec 8, 2023Material Deformation; Positioning Problem; Material Deformation; Positioning Problem

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A LESION. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. IT WAS DETAILED THAT WHEN THE STENT WAS REMOVED FROM THE GUIDE CATHETER FOLLOWING A FAILURE TO CROSS THE LESION, THE STENT STRUT WAS NOTED TO BE BENT AWAY FROM DELIVERY BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME SIZE ONYX FRONTIER STENT. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18295369 ↗
• MalfunctionNov 27, 2023Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS, MODERATELY CALCIFIED LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. 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. THE DEVICE WAS NOT KINKED AND RE-STRAIGHTENED DURING USE. IT WAS REPORTED THAT THE BALLOON DETACHED FROM THE DELIVERY SYSTEM AFTER STENT DELIVERY, DURING REMOVAL OF THE DEVICE. THE BALLOON DETACHED WHILE BEING PULLED IN THE NON-MEDTRONIC GUIDE EXTENSION CATHETER. THE DETACHED PORTION DOES NOT REMAIN IN THE PATIENT. ALL COMPONENTS OF THE DEVICE WERE REMOVED TOGETHER THROUGH THE GUIDE, WITH THE DELIVERY SYSTEM REMAINING ON THE WIRE. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18211794 ↗
• MalfunctionSep 26, 2023Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE AN ONYX FRONTIER DRUG ELUTING STENT (DES) TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION IN THE PROXIMAL CIRCUMFLEX (CX) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS NOT PRE-DILATED. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION. THE DISLODGED STENT WAS REMOVED. IT WAS DETAILED THAT THE STENT WAS REMOVED BY LOW ATMOSPHERE (ATM) INFLATION AND PULLED INTO AND TRAPPED IN A GUIDE EXTENSION CATHETER (GEC). NO PATIENT INJURY WAS REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17815743 ↗
• MalfunctionAug 3, 2023Defective Component; Material Deformation; Defective Component; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A NON-TORTUOUS, MODERATELY CALCIFIED LESION WITH 65% STENOSIS IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. ARTERY DIAMETER WAS 3.5MM AND LESION LENGTH 28MM. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. 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. THE STENT WAS INFLATED TO 13 ATM. IT WAS REPORTED THAT UPON DEPLOYMENT, WHILE THE BALLOON WAS INFLATED, THAT THE STENT LOOKED LARGER THAN THE EXPECTED 3.5MM DIAMETER, AND WHILE ON FLUOROSCOPY THE BALLOON APPEARED TO INCREASE IN DIAMETER BEYOND THE 3.50MM EXPECTED AT 13 ATM. POST STENT DEPLOYMENT INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED. THE RESULTING IVUS SHOWED A 4.2MM INNER DIAMETER OF THE DEPLOYED STENT. AN NON-MEDTRONIC INDEFLATOR WAS USED. THE SAME INFLATION DEVICE WAS USED PREVIOUSLY ON OTHER DEVICES WITH NO ISSUES. THERE WAS NO ADDITIONAL INTERVENTION NEEDED OR PERFORMED. A 6F GUIDE CATHETER WAS ALSO USED DURING THE PROCURE TO WHICH THERE IS NO COMPLAINT. THE PATIENT IS ALI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17448147 ↗