Onyx Frontier™ ONYXNG35038UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00763000511623), received between Sep 28, 2022 and Jun 13, 2025 — classified as 4 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 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 INVOLVING ONE ONYX FRONTIER CORONARY DRUG-ELUTING STENT, ATTEMPTS WERE MADE TO CROSS THE RIGHT CORONARY ARTERY (RCA) LESION BUT THE STENT WOULD NOT CROSS THE LESION AND BEGAN TO STRIP OFF THE BALLOON. THE DEVICE COULD NOT BE RETRACTED INTO THE GUIDE CATHETER. THE ENTIRE BALLOON/STENT/GUIDE CATHETER WAS PULLED BACK INTO THE RADIAL ARTERY BUT THE STENT COULD NOT BE RETRACTED INTO THE 6FR SHEATH. THE STENT WAS THEN DEPLOYED IN THE RIGHT RADIAL ARTERY. THE PROCEDURE WAS COMPLETED AS INTENDED WITH NO HARM TO THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22200730 ↗
• InjuryMay 8, 2025Migration or Expulsion of Device; Device Dislodged or Dislocated; Migration or Expulsion of Device; Device Dislodged or Dislocated

  DURING A LEFT HEART CATHETERIZATION PROCEDURE INVOLVING AN ONYX FRONTIER CORONARY STENT, FLUOROSCOPY REVEALED THAT THE STENT HAD SLIGHTLY MIGRATED FROM THE BALLOON. THE PATIENT, WHO PRESENTED WITH SEVERE AORTIC STENOSIS, HAD THE DEVICE POSITIONED IN THE MID-SEGMENT OF THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE STENT WAS INTENDED TO BE DEPLOYED AT THIS LOCATION, WHICH WAS APPROPRIATE; HOWEVER, THE BALLOON WAS UNABLE TO ADVANCE TO THE DISTAL PORTION OF THE STENT. AS A RESULT, THE BALLOON WAS REMOVED AND REPLACED WITH A 2.5X12 MM BALLOON, WHICH WAS INSERTED INTO THE STENT WHICH WAS STILL IN POSITION. THE PATIENT TOLERATED THE PROCEDURE WELL, AND NO HARM OR COMPLICATIONS WERE REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 21989674 ↗
• MalfunctionApr 28, 2025Activation, Positioning or Separation Problem; Device Dislodged or Dislocated; Activation, Positioning or Separation Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT DEPLOYMENT ISSUES WERE ENCOUNTERED. IT WAS NOTED THAT UPON DEPLOYMENT WHEN MOVING THE DEVICE, THE BALLOON COLLAPSED AND THE STENT DISLODGED. STENT DISLODGMENT OCCURRED FOLLOWING FAILED DELIVERY. THE LESION BEING TREATED WAS SEVERELY TORTUOUS AND SEVERELY CALCIFIED LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE DISLODGED STENT WAS REMOVED FROM THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21918461 ↗
• MalfunctionApr 7, 2025Detachment of Device or Device Component; Device Dislodged or Dislocated; Material Deformation; Detachment of Device or Device Component; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG-ELUTING STENT, THE DEVICE DETACHED, CRACKED OR FRACTURED DURING REMOVAL POST DEPLOYMENT OF THE STENT. THE LESION BEING TREATED WAS MODERATELY TORTUOUS AND MODERATE CALCIFIED. THE DEVICE WAS NOT INSPECTED PRIOR TO USE. THE DEVICE WAS NOT KINKED OR RE-STRAIGHTENED DURING USE. THE LESION WAS PRE-DILATED. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE STENT WAS PLACED IN THE VESSEL AND THE STENT DELIVERY SYSTEM WAS REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21783781 ↗
• InjuryJul 25, 2024Deflation Problem; Difficult to Remove; Detachment of Device or Device Component; Device Dislodged or Dislocated; Material Deformation; Positioning Problem; Deflation Problem; Difficult to Remove; Detachment of Device or Device Component; Device Dislodged or Dislocated; Material Deformation; Positioning Problem

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A SEVERELY CALCIFIED, SEVERELY TORTUOUS LESION IN THE OSTIUM/PROXIMAL CIRCUMFLEX ARTERY (CX). 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 NOTED WHILE ADVANCING THE DEVICE. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. STENT DISLODGEMENT ALSO OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. THE DISLODGED STENT WAS EXPANDED IN THE PROXIMAL CX AND LEFT MAIN, HOWEVER, BALLOON DEFLATION DIFFICULTIES OCCURRED, AND THE DEVICE WOULD NOT DEFLATE AT THE LESION SITE. MANY METHODS WERE ATTEMPTED TO PUNCTURE THE BALLOON, AND DURING THE PUNCTURE ATTEMPTS THE CATHETER BROKE PROXIMAL TO THE BALLOON. THE PROCEDURE WAS NOT COMPLETED, AND AFTER MANY ATTEMPTS THE PATIENT WAS SENT TO CARDIOTHORACIC SURGERY (CT). THE CT SURGERY WAS A SUCCESS, AND THE PATIENT WAS EXTUBATED AND WAS AWAKE AND ALERT. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

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

  MAUDE report 19826408 ↗
• InjuryApr 15, 2024Deflation Problem; Detachment of Device or Device Component; Material Deformation; Deflation Problem; Detachment of Device or Device Component; Material Deformation

  THE PATIENT PRESENTED TO HOSPITAL WITH A NON-ST-ELEVATION MYOCARDIAL INFARCTION (NSTEMI), INDICATED WITH ELEVATED ENZYMES. AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT (DES) TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 90% STENOSIS IN THE DISTAL LEFT MAIN (LM) CORONARY 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. IT WAS REPORTED THAT THE DEVICE WOULD NOT DEFLATE AT THE LESION SITE. THE LEFT ANTERIOR DESCENDING (LAD) ARTERY AND THE DISTAL LEFT MAIN WERE PRE-DILATED WITH A 2.0X15MM EUPHORA BALLOON FOR SEVERAL INFLATIONS UP TO 14 ATM. THE BALLOON WAS REMOVED WITH EASE WITH NO COMPLICATIONS. A NON-MEDTRONIC (MDT) GUIDE EXTENSION CATHETER (GEC) WAS INSERTED ALONG WITH AN 2.0X15MM NC EUPHORA BALLOON TO THE LAD AND LM, AND SEVERAL INFLATIONS AS HIGH AS 20 ATM WERE COMPLETED. THE BALLOON WAS REMOVED WITH EASE WITH NO COMPLICATIONS, ALONG WITH THE GEC. A 3.5X12MM NON-MEDTRONIC INTRAVASCULAR LITHOTRIPSY DEVICE

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

  MAUDE report 19104803 ↗
• MalfunctionOct 26, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG-ELUTING STENT DURING A PROCEDURE TO TREAT A LESION. IT WAS REPORTED THAT THE STENT SHAFT BROKE ON INSERTION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18015567 ↗
• MalfunctionJun 22, 2023Premature Activation; Use of Device Problem; Premature Activation; Use of Device Problem

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED LESION IN THE MID RIGHT CORONARY ARTERY (RCA). 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 NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT WHEN THE STENT WAS DELIVERED TO THE LESION IT WAS NOTICED UNDER FLUOROSCOPY THAT EACH MARKER BAND HAD A CIRCLE OR LIGHTBULB EFFECT, APPEARING LIKE THE BALLOON WAS INFLATED. IT WAS DETAILED THAT THE INDEFLATOR WAS NOT CONNECTED AND NO AIR WAS USED IN THE CATHETER AT THAT STAGE. THE STENT WAS REMOVED AND ANOTHER STENT OF THE SAME SIZE WAS INSERTED AND DEPLOYED. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17182655 ↗
• MalfunctionNov 16, 2022Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A LESION. IT WAS REPORTED THAT THE STENT FAILED TO CROSS THE LESION AND THE STENT WAS DAMAGED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15803204 ↗
• MalfunctionOct 26, 2022Burst Container or Vessel; Deflation Problem; Difficult to Remove; Burst Container or Vessel; Deflation Problem; Difficult to Remove

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED LESION WITH 90% STENOSIS IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). 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 NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT A BALLOON BURST, LEAK OR CATHETER LEAK OCCURRED DURING STENT DEPLOYMENT. THE BALLOON BURST/LEAK/RUPTURE OCCURRED AT 20 ATM. THE INFLATIONS WERE APPLIED AT 20ATM FOR 18 SECONDS AND 20ATM FOR 16 SECONDS. THE STENT WAS SUCCESSFULLY DEPLOYED HOWEVER THE STENT DELIVERY SYSTEM WOULD NOT ENTER BACK INTO THE GUIDE CATHETER AFTER DEFLATION. IT WAS STATED THAT THERE WAS A DEFLATION ISSUE. THE STENT DELIVERY SYSTEM, GUIDEWIRE AND GUIDE CATHETER HAD TO BE REMOVED ALL TOGETHER. AFTER REMOVAL OF THE DEVICE IT WAS NOTICED THAT THE END OF THE STENT DELIVERY SYSTEM BALLOON WAS ENLARGED WHICH EXPLAINED THE REASON THE BALLOON WOULD NOT ENTER THE GUIDE CATHETER. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15672258 ↗
• InjurySep 28, 2022Device Damaged by Another Device; Device Dislodged or Dislocated; 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 MILDLY TORTUOUS, MODERATELY CALCIFIED LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA) WITH CHRONIC TOTAL OCCLUSION 100% (CTO). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS USED DURING DELIVERY. IT WAS REPORTED THAT THE STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT THE LESION. THE DISLODGED STENT WAS NOT REMOVED FROM THE PATIENT. AN ATTEMPT TO CRUSH THE STENT TO THE WALL WAS UNSUCCESSFUL AND NO BALLOON WAS ABLE TO GET AROUND THE DISLODGED STENT. IT WAS STATED THAT STENTS WERE DEPLOYED PROXIMAL AND DISTAL IN THE RIGHT CORONARY ARTERY (RCA) AND THE DISLODGED STENT PRESUMABLY CAUGHT ON THE DEPLOYED STENT IN THE PROXIMAL RCA. NO FURTHER INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15500458 ↗