Onyx Frontier™ ONYXNG22518UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00763000511210), received between Oct 25, 2022 and Aug 7, 2026 — classified as 10 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (10 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2026Device Dislodged or Dislocated; Positioning Problem

  During a procedure an attempt was made to use one Onyx Frontier coronary Drug Eluting Stent when there was difficulties with the stent crossing a heavily calcified lesion and the stent come off the delivery system while trying to advance into the lesion. The stent was crushed to the side wall with good results. The procedure required atherectomy and multiple stents. No patient complications were reported as a result of the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50175698 ↗
• InjuryNov 18, 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 TORTUOUS WITH 99% STENOSIS IN THE MID CIRCUMFLEX (CX) ARTERY. THE DEVICE WAS INSPECTED PRIOR TO USE 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 OR CELL OF A STENT. RESISTANCE WAS NOT NOTED WHEN ADVANCING THE DEVICE. RESISTANCE WAS NOT NOTED DURING WITHDRAWAL OF THE DEVICE. THE ANGIOPLASTY WAS STARTED WITH A 2.0 NON COMPLIANT (NC) BALLOON. IT WAS ATTEMPTED TO DELIVER THE STENT HOWEVER IT COULD NOT BE DELIVERED. THE STENT STRIPPED OFF THE STENT BALLOON AS IT WAS BEING REMOVED FROM THE CX. A 1.0 NON-MEDTRONIC BALLOON WAS USED TO GET PART-WAY INTO THE STENT AND WAS THEN INFLATED TO ATTEMPT TO RETRACT THE STENT MORE PROXIMALLY. THEN A 7MM GOOSENECK SNARE WAS USED TO FULLY RETRACT THE STENT INTO THE GUIDE CATHETER AND THE DISLODGED STENT WAS SUCCESSFULLY REMOVED WITHOUT COMPLICATION. AT THE END OF THE PROCEDURE THERE WAS 40% RESIDUAL STENOSIS AND TIMI 3 FLOW. NO FURTHER PATIENT C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23579815 ↗
• InjuryJun 9, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A PROCEDURE TWO ONYX FRONTIER CORONARY DRUG ELUTING STENTS DISLODGED DURING DELIVERY TO/AT LESION. THE LESION BEING TREATED WAS MODERATELY TORTUOUS LOCATED IN THE OSTIUM LEFT MAIN (LM) CORONARY ARTERY. THE DEVICES DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THE 2.25X18MM ONYX FRONTIER STENT HAD TO BE CRUSHED AT THE LESION USING A NON-MEDTRONIC STENT. THE 4.00X18MM ONYX FRONTIER STENT WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22165004 ↗
• MalfunctionMar 5, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT DISLODGED DURING USE. THE STENT WAS NOT ON THE CATHETER WHEN THE STENT DELIVERY SYSTEM (SDS) EXITED THE GUIDE CATHETER TO BE DELIVERED TO THE LESION SITE. THIS WAS A COMPLEX LEFT ANTERIOR DESCENDING (LAD) ARTERY/DIAGONAL BIFURCATION CASE. THE LESION BEING TREATED WAS MODERATELY CALCIFIED IN THE PROXIMAL DIAGONAL BRANCH. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS NOT INSPECTED BEFORE USE. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS DETAILED THAT THERE WERE TWO WIRES IN THE GUIDE, SO RESISTANCE WAS EXPECTED, AND AFTER PUSHING THROUGH SOME RESISTANCE IT WAS NOTICED THERE WAS NO STENT ON THE SDS. ALL EQUIPMENT WAS THEN REMOVED FROM THE PATIENT. THE GUIDE CATHETER WAS SCANNED BUT DID NOT FIND THE DISLODGED STENT. THE PATIENT UNDERWENT A WHOLE-BODY CT SCAN WHICH CONFIRMED THAT THE STENT WAS NOT DISLODGED IN THE PATIENT. IT WAS BELIEVED THAT THE STENT WAS NOT ON THE CATHETER FROM THE OUTSET O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21523688 ↗
• MalfunctionOct 15, 2024Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A SEVERELY CALCIFIED LESION LOCATED IN THE MID DIAGONAL BRANCH. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED WITH 2.0X12MM AND 2.5X12MM NON-MEDTRONIC BALLOONS. 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 STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT THE LESION. THE DISLODGED STENT WAS REMOVED. IT WAS POSSIBLE TO PULL THE STENT OUT AS IT WAS STILL ON THE WIRE. IT WAS DETAILED THAT AN OLD STENT WAS ALREADY IMPLANTED IN 1ST DIAGONAL AND AN ATTEMPT WAS BEING MADE TO GET THE ONYX FRONTIER TO THE 2ND DIAGONAL. THE LESION WAS INSTEAD TREATED WITH JUST BALLOONING OF THE 1ST DIAGONAL AREA TO MAKE SURE THE PREVIOUSLY IMPLANTED STENT WAS STILL OPEN. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20451414 ↗
• InjuryAug 20, 2024Entrapment of Device; Device Dislodged or Dislocated; Entrapment of Device; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A NON-TORTUOUS, MODERATELY CALCIFIED LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED 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. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT THE LESION. AN ATTEMPT WAS MADE TO DELIVER THE 2.25 X 18 ONYX FRONTIER STENT TO THE MID LAD AND THE DIAGONAL BIFURCATION, BUT FRICTION WAS FELT WHEN THE STENT PASSED THROUGH THE PREVIOUSLY IMPLANTED STENT (FROM 2019). DURING ATTEMPTS TO WITHDRAW THE STENT DELIVERY SYSTEM, THERE WAS RESISTANCE FELT. UPON REMOVAL OF DELIVERY SYSTEM, THE BALLOON WAS INSPECTED AND THE STENT WAS NOT PRESENT. UNDER FLOURO, THE STENT WAS SEEN TO HAVE DISLODGED IN THE MID LAD. IT WAS THEN ATTEMPTED TO DELIVER A BALLOON TO CRUSH STENT AGAINST VESSEL WALL BUT WAS UNSUCCESSFUL IN DELIVERING THE BALLOON. THE STENT WAS NOT REMOVED FROM THE PATIENT. THE PATIENT REPORTED TO BE STABLE AND WAS TRANSFERRED TO ANOT

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

  MAUDE report 20001992 ↗
• InjuryJun 10, 2024Activation, Positioning or Separation Problem; Device Dislodged or Dislocated; Positioning Problem; Activation, Positioning or Separation Problem; Device Dislodged or Dislocated; Positioning Problem

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER DRUG ELUTING STENT TO TREAT A LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. IT WAS REPORTED THAT THE STENT WAS REMOVED AFTER A FAILED DELIVERY ATTEMPT AND WAS NOTED TO HAVE BEEN SHEARED OFF THE BALLOON. THE STENT WOULD NOT CROSS THE LEFT MAIN DUE TO FRICTIONAL RESISTANCE. THE STENT WAS RETRIEVED FROM THE GUIDE WITHOUT DIFFICULTY. A 5FR NON-MEDTRONIC GUIDE EXTENSION CATHETER WAS THEN ADVANCED OVER THE 2.0 BALLOON INTO THE PROXIMAL LAD AND DEPLOYED AT 10-12 ATM. UNDER EXPANSION OF THE PROXIMAL STENT PORTION WAS NOTED. A 2.5X12MM BALLOON WAS USED TO POST DILATE THE PROXIMAL HALF OF THE STENT AT 18 ATM. FINAL ANGIOGRAPHIC IMAGES CONFIRMED AN EXCELLENT RESULT IN THE TREATED ZONE WITHOUT COMPLICATION. THERE WAS NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19503592 ↗
• InjuryMay 8, 2024Burst Container or Vessel; Difficult to Remove; Activation, Positioning or Separation Problem; Burst Container or Vessel; Difficult to Remove; Activation, Positioning or Separation Problem

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT (DES) TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION EXHIBITING 85% STENOSIS LOCATED IN THE PROXIMAL CIRCUMFLEX (CX) ARTERY. 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 DELIVERY. IT WAS REPORTED THAT A BALLOON BURST OCCURRED DURING STENT DEPLOYMENT ON THE FIRST INFLATION AT 10 ATM. THE BALLOON RUPTURED AND THE DEVICE WAS PULLED BACK INTO THE LEFT MAIN WHICH ALSO PULLED THE STENT BACK INTO THE LEFT MAIN, WITH HALF OF THE STENTS LENGTH LEFT IN THE CIRCUMFLEX ARTERY. A 2.0MM X 20 EUPHORA BALLOON WAS PLACED IN THE STENT AND A PRESSURE OF 4 ATM WAS APPLIED TO TRY TO PULL THE STENT OUT THROUGH THE GUIDE WITHOUT SUCCESS. A 2.0 X 12 NON-MEDTRONIC BALLOON WAS THEN USED WITH UP TO 6 ATM OF PRESSURE APPLIED TO TRY TO PULL THE STENT OUT THROUGH THE GUIDE WITH NO SUCCESS. A 4.0 X 8MM ONYX FRONTIER DES WAS THEN DEPLOYED WITHIN THE 2.25 X 18 ONYX FRONTIER STENT

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

  MAUDE report 19267887 ↗
• MalfunctionApr 8, 2024Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A LESION. 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 THERE WERE DIFFICULTIES REMOVING THE DEVICE FOLLOWING STENT DEPLOYMENT. IT WAS DETAILED THAT THE STENT WAS INSERTED AND DEPLOYED SUCCESSFULLY BUT THE STENT WAS UNABLE TO BE REMOVED FROM THE WIRE. THE WIRE AND STENT HAD TO BE REMOVED TOGETHER OUT OF THE BODY. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19061010 ↗
• InjurySep 25, 2023Difficult to Remove; Device Damaged by Another Device; Device Dislodged or Dislocated; Difficult to Remove; Device Damaged by Another Device; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT (DES) TO TREAT A MODERATELY TORTUOUS LESION IN THE LEFT MAIN (LM) CORONARY ARTERY. 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 ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT THE LESION. IT WAS DETAILED THAT THE ONYX FRONTIER STENT WAS GOING THROUGH A FRESHLY DEPLOYED STENT AND THE ONYX FRONTIER STENT STRIPPED OFF. THE DISLODGED STENT WAS REMOVED FROM THE AORTA WITH A SNARE WITH NO ISSUES. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 17813609 ↗
• InjuryApr 26, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A VERY TORTUOUS AND CALCIFIED LESION IN THE MID RIGHT CORONARY ARTERY (RCA). THERE WERE NO ISSUES WITH THE DEVICE WHEN REMOVED FROM THE HOOP. NEGATIVE PREP WAS PERFORMED OUTSIDE THE BODY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING ADVANCEMENT TO THE LESION. IT WAS DETAILED THAT ACCESS WAS OBTAINED VIA THE RIGHT RADIAL AND A 6FR GUIDE CATHETER AND NON-MEDTRONIC WIRE WERE USED. THE LESION WAS PREDILATED WITH A 2.0 X 12MM EUPHORA BALLOON CATHETER. AN ATTEMPT WAS THEN MADE TO ADVANCE THE ONYX FRONTIER STENT DOWN TO THE LESION. THE STENT CAME OFF THE BALLOON DUE TO THE CALCIFICATION AND TORTUOSITY OF THE VESSEL. USING A NON-MEDTRONIC WIRE AS A BUDDY WIRE, A 1.25 OTW SPRINTER BALLOON CATHETER WAS USED TO DILATE THE DISLODGED STENT. THE STENT WAS DILATED AND PLACED PROXIMAL TO THE LESION. AN ATTEMPT WAS THEN MADE TO PUT A 2.25 X 12MM ONYX FRONTIER STENT THROUGH THE NEWLY DEPLOYED STENT. HOWEVER, IT WAS DECIDED TO STOP AS THE 2.25 X 12MM STENT WOULD NOT GO THROUGH THE IMPLANTED STENT. THE PATIENT WAS STABLE WITH TIMI III FLOW. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY FOR TREATMENT OF THE O

  Patient problems: Insufficient Information

  MAUDE report 16814064 ↗
• InjuryNov 4, 2022Difficult to Insert; Device Dislodged or Dislocated; Difficult to Insert; 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 DISLODGED STENT WAS NOT REMOVED. NO PATIENT INJURY WAS REPORTED.

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

  MAUDE report 15733021 ↗
• InjuryOct 25, 2022Migration or Expulsion of Device; Material Deformation; Migration or Expulsion of Device; Material Deformation

  AN ATTEMPT WAS MADE TO USE TWO ONYX FRONTIER DRUG ELUTING STENT'S (DES) TO TREAT A SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 90% STENOSIS IN THE OSTIUM LEFT MAIN CORONARY ARTERY AND THE PROXIMAL DIAGONAL BRANCH. THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED FOR BOTH DEVICES WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICES. EXCESSIVE FORCE WAS NOT USED DURING THE DELIVERY OF THE DEVICES. THE SECOND STENT ONYXNG25030UX (PLI20) PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. ONYXNG25030UX (PLI20) WAS NOT KINKED AND RE-STRAIGHTENED DURING USE. FOR THE FIRST STENT USED, ONYXNG22518UX (PLI10), IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO POST DEPLOYMENT. FOR THE SECOND ONYX FRONTIER DRUG ELUTING STENT, ONYXNG25030UX (PLI20), IT WAS REPORTED THAT WIRE MOVEMENT ISSUES OCCURRED AND THERE WAS POOR GUIDEWIRE MOVEMENT DURING THE PROCEDURE. THE STENTS WERE DEPLOYED WITH A NON MDT WIRE TRAPPED BEHIND THE DEPLOYED ONYX FRONTIER. THE WIRE MOVEMENT ISSUES OCCURRED WITH A NON MDT WIRE WHICH BECAME TRAPPED AGAINST THE LAD TO OSTIUM BEHIND A NON MDT CORONARY DILATION CATHETER WHICH LED TO THE STENT

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

  MAUDE report 15665919 ↗