Onyx Frontier™ ONYXNG20008UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00763000511111), received between Oct 20, 2022 and Aug 7, 2026 — classified as 9 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (11 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  During the index procedure one Prevail Drug coated balloon (DCB) was used to treat a lesion with 80% stenosis located in the 1st Diagonal artery. Two Onyx Frontier were also implanted in the 1st Diagonal during a second intervention on the same day post the index procedure. Approximately 1 month post the index procedure, the CEC adjudicated that the patient suffered from acute lesion thrombosis, ARC definite.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Thrombosis/Thrombus

  MAUDE report 50170434 ↗
• MalfunctionMay 28, 2026Device Dislodged or Dislocated

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT WHEN STENT DISLODGMENT OCCURRED DURING REMOVAL OF THE SHEATH. WHEN THE SHEATH WAS PULLED OFF THE BALLOON MOUNTED STENT, THE STENT REMAINED INSIDE THE SHEATH. IT WAS LATER REPORTED THAT IT WAS UNKNOWN WHETHER THE STENT BECAME DISLODGED DURING THE PREPARATION PROCESS. HOWEVER, AFTER THE BALLOON HAD BEEN INTRODUCED INTO THE PATIENT¿S BODY, IT WAS NOTED THAT THE STENT WAS NOT ON THE BALLOON. THE STENT WAS SUBSEQUENTLY FOUND INSIDE THE PROTECTIVE SLEEVE, WHICH HAD BEEN DISCARDED AND WAS LATER RECOVERED FROM THE TRASH. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE LESION INTENDED TO BE TREATED WAS A MODERATELY TORTUOUS LESION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25325393 ↗
• MalfunctionApr 24, 2026Use of Device Problem

  IT WAS REPORTED THAT ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT WAS APPROXIMATELY 11 DAYS EXPIRED WHEN IT WAS IMPLANTED IN THE PATIENT. THE PROCEDURE WAS SUCCESSFUL. IT WAS NOT REALISED UNTIL AFTER THE PROCEDURE WAS COMPLETED THAT THE DEPLOYED STENT WAS EXPIRED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24980518 ↗
• InjuryJan 16, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT DISLODGED IN VIVO IN THE LEFT MAIN (LM) ARTERY. THE STENT CAME OFF THE BALLOON PRIOR TO DEPLOYMENT. THE STENT WAS UNABLE TO BE RETRIEVED AND WAS THEREFORE PUSHED INTO THE LEFT ANTERIOR DESCENDING (LAD) ARTERY TO PREVENT BLOCKING THE LM ARTERY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24093607 ↗
• InjuryApr 28, 2025Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT CAME OFF THE BALLOON WHILE ATTEMPTING TO GET INTO THE APPROPRIATE POSITION. AN ATTEMPT WAS MADE TO ADVANCE THE STENT INTO THE PROXIMAL/MID LEFT CIRCUMFLEX (CX) ARTERY, HOWEVER, THERE WAS SIGNIFICANT DIFFICULTY ADVANCING THE STENT INTO THE LESION. THE CX WAS STENOSED WITH A BLOCKAGE. WHILE REMOVING THE STENT IT WAS NOTICED THAT THE STENT CAME OFF THE BALLOON. THE STENT BALLOON WAS THEN REMOVED, AND A 1.0 MM NON-MEDTRONIC BALLOON WAS ADVANCED INTO THE PROXIMAL PORTION OF THE STENT AND INFLATED TO OPEN THE DISLODGED STENT. THE DISLODGED STENT WAS DEPLOYED AND APPROPRIATELY OPPOSED TO VESSEL WALL WHERE IT WAS INTENDED TO BE DEPLOYED. ANGIOGRAPHY WAS PERFORMED IN THE PROXIMAL/MID CX, AND THE STENOSIS WAS SIGNIFICANTLY REDUCED TO 10-20% WITH THROMBOLYSIS IN MYOCARDIAL INFARCTION-3 (TIMI-3) FLOW DISTALLY. THE PATIENT WAS STABLE THROUGHOUT PROCEDURE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 21917445 ↗
• InjuryJan 17, 2025Device Dislodged or Dislocated; Positioning Problem; Device Dislodged or Dislocated; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING AN ONYX FRONTIER CORONARY DRUG ELUTING STENT (DES), STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. THE LESION BEING TREATED WAS IN THE RAMUS. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE DISLODGED STENT WAS NOT REMOVED FROM THE PATIENT. ANOTHER STENT WAS USED TO CRUSH THE DISLODGED STENT WITHIN THE VESSEL. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 21177110 ↗
• InjurySep 3, 2024Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT AND ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 80% STENOSIS IN THE DISTAL CIRCUMFLEX (CX) ARTERY AND OBTUSE MARGINAL (OM). BOTH DEVICES WERE INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED ON THE RESOLUTE ONYX DEVICE. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES ON THE ONYX FRONTIER DEVICE. THE LESION WAS PRE-DILATED. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICES. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY OF THE DEVICES. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT LESION. AN ATTEMPT WAS FIRST MADE TO PLACE THE RESOLUTE ONYX STENT INTO THE DISTAL OM, AFTER PRE-DILATION, USING A NON-MEDTRONIC GUIDE EXTENSION CATHETER FOR ADDITIONAL SUPPORT. THE CX WAS HEAVILY CALCIFIED AND PREVENTED DELIVERY OF THE STENT TO THE OM. THE RESOLUTE ONYX STENT DISLODGED AND WAS REMOVED FROM THE PATIENT BY INFLATING A 1. 25X6MM SPRINTER BALLOON INTO THE LUMEN OF THE STENT AND PULLING THE STENT BACK INTO THE GUIDE, SUCCESSFULLY REMOVING IT FROM THE BODY. AN ATTEMPT

  Patient problems: Insufficient Information

  MAUDE report 20123683 ↗
• InjuryMay 10, 2024Deformation Due to Compressive Stress; Device Dislodged or Dislocated; Positioning Problem; Deformation Due to Compressive Stress; Device Dislodged or Dislocated; Positioning Problem

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A SEVERELY TORTUOUS, MILDLY CALCIFIED LESION WITH 90% STENOSIS IN THE MID/OSTIUM OBTUSE MARGINAL (OM). THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT DEVICE PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. BIFURCATION STENTING WAS PLANNED, WITH THE INITIAL STENT BEING PLACED ACROSS THE BRANCH IN QUESTION. ONCE THE SECOND WIRE WAS REPLACED, THE WIRE WAS NOT THROUGH THE INITIAL STENT, BUT WAS OUTSIDE THE STENT. THE ONYX FRONTIER STENT WAS BEING USED AS THE SECONDARY BRANCH STENT. THE ONYX FRONTIER WOULD NOT ADVANCE BECAUSE IT WAS BEHIND THE INITIAL STENT, AND WHEN AN ATTEMPT WAS MADE TO REMOVE THE ONYX FRONTIER STENT IT WAS PINNED AND CAME OFF OF THE BALLOON. A BALLOON WAS INSERTED INTO THE VESSEL AND DILATED TO CRUSH THE DISLODGED ONYX FRONTIER STENT IN PLACE BEHIND THE INITIAL STENT. A DISSECTION OF THE BRANCHING ARTERY OCCURRED, WHICH WAS THROUGH THE I

  Patient problems: Insufficient Information; Vascular Dissection

  MAUDE report 19284558 ↗
• InjuryNov 24, 2023Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT (DES) TO TREAT A MILDLY TORTUOUS LESION IN THE 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 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 ATTEMPTED TO RETRIEVE THE DISLODGED STENT BUT, IT FAILED TO BE REMOVE. THE DISLODGED STENT WAS BALLOONED IN PLACE. NO FURTHER PATIENT INJURY WAS REPORTED.

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

  MAUDE report 18204865 ↗
• MalfunctionAug 29, 2023Defective Component; Material Deformation; Defective Component; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE 2.00X8MM ONYX FRONTIER CORONARY DRUG ELUTING STENT (DES) TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED LESION WITH 70% STENOSIS IN THE MID OBTUSE MARGINAL (OM). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. 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 THE DELIVERY. IT WAS REPORTED THAT THE 2.00X8MM ONYX FRONTIER APPEARED TO BE LONGER THAN 8MM. IT WAS DETAILED THAT POST STENT IMPLANTATION THE DISTAL PORTION OF A NON-MEDTRONIC WIRE, WHICH WAS STATED TO BE 15MM WAS USED TO MEASURE THE STENT LENGTH. THE STENT APPEARED TO BE APPROXIMATELY THREE QUARTERS THE SIZE OF THE NON-MEDTRONIC WIRE WHICH MEANT THE STENT LENGTH WAS ESTIMATED TO BE 12MM. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17642853 ↗
• InjuryAug 28, 2023Device Dislodged or Dislocated; Positioning Problem; Device Dislodged or Dislocated; Positioning Problem

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT (DES) TO TREAT A LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED PRIOR TO STENT DEPLOYMENT. IT WAS DETAILED THAT WHEN ATTEMPTING TO ADVANCE THE STENT DISTALLY IT WAS MET WITH RESISTANCE POSSIBLY DUE TO THE PRESENCE OF PLAQUE. THE STENT WAS REMOVED AND IT WAS FOUND THAT THE STENT WAS NOT ON THE BALLOON. THE DISLODGED STENT WAS DESCRIBED AS FREE FLOATING IN RCA. AN ENQUIRY WAS MADE ON THE RECOMMENDED STEPS TO REMOVE A DISLODGED STENT. QUESTIONS WERE ANSWERED AND EDUCATION/DOCUMENTATION WAS PROVIDED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17637736 ↗
• InjuryFeb 7, 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 TORTUOUS, MILDLY CALCIFIED LESION WITH 80% STENOSIS LESION IN MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. ABNORMALITIES WERE REPORTED IN RELATION TO THE PATIENT'S ANATOMY AS A 90-DEGREE BEND IN LAD WAS NOTED. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. A 2.0 X 12MM BALLOON WAS USED TO PRE-DILATE THE LESION AT 8ATM WHICH SHOWED AN IMPROVEMENT IN THE DEGREE OF STENOSIS ON THE ANGIOGRAPHY. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING THE REMOVAL OF THE DEVICE FOLLOWING A FAILED DELIVERY. DESPITE THE USE OF A NON MDT GUIDE EXTENSION CATHETER, IT WAS NOT POSSIBLE TO DELIVER THE STENT TO THE LESION. DURING AN ATTEMPT TO PASS THE 2.0 X 8 MM ONYX FRONTIER THROUGH THE LESION, THE STENT WAS STRIPPED. USING A WIRE EXTENSION AND A TELEMARK DEVICE, IT WAS EXCHANGED FOR A WIGGLE WIRE. THEN, A 1.25 X 12 SPRINTER LEGEND BALLOON WAS ADVANCED AND INFLATED INSIDE THE STENT. IT WAS THEN POSSIBLE TO PULL BACK AND RETRIEVE THE

  Patient problems: Insufficient Information

  MAUDE report 16311573 ↗
• MalfunctionJan 5, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 95% STENOSIS, IN THE MID CIRCUMFLEX (CX) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED WITH A 2.0 X 15MM AND 2.5 X 15MM NC BALLOONS. THE DEVICE DID NOT PASS THOUGHT A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS USED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION. AN ATTEMPT WAS MADE TO DELIVER THE STENT IN AN ACUTE ANGLED CALCIFIED CX, HOWEVER, THE STENT FAILED TO CROSS THE LESION DUE TO THE CALCIFICATION. THE STENT DELIVERY SYSTEM WAS REMOVED AND IT WAS NOTED THAT THE STENT WAS NOT ON THE DELIVERY BALLOON. A 6F LAUNCHER GUIDE CATHETER AND A NON-MEDTRONIC GUIDE EXTENSION CATHETER (GEC) WERE ALSO USED. THE DISLODGED STENT WAS NOT REMOVED AND THE STENT WAS NOT LOCATED. IT WAS THOUGH THAT THE STENT MAY HAVE DISLODGED IN THE NON-MEDTRONIC GEC OR THE SHEATH ,HOWEVER, THIS WAS NOT CONFIRMED. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16100931 ↗
• MalfunctionOct 20, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A LESION. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS NOT PRE-DILATED. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS USED. THE DEVICE WAS NOT KINKED AND RE-STRAIGHTENED DURING USE. IT WAS REPORTED THAT THE DEVICE FAILED TO CROSS THE LESION. IT WAS ALSO REPORTED THAT THE STENT DISLODGED/DISPLACED/FELL OFF THE BALLOON IN VITRO, AFTER THE REMOVAL OF THE DEVICE. IT WAS CONFIRMED THAT THE DEVICE DID NOT DETACH, CRACK OR FRACTURE. NO DETACHED PORTION OF DEVICE REMAINED IN THE PATIENT. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15638051 ↗