Onyx Frontier™ ONYXNG30026UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00763000511500), received between Apr 11, 2023 and Mar 5, 2026 — classified as 1 death, 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (8 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.

• InjuryMar 5, 2026Device Dislodged or Dislocated; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING TWO ONYX FRONTIER CORONARY DRUG ELUTING STENTS, STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT LESION LOCATED IN THE MID CIRCUMFLEX (CX) ARTERY, WHICH EXHIBITED SEVERE CALCIFICATION AND HEAVY CALCIUM AT THE LESION. BOTH DEVICES WERE INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. BOTH DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF BOTH DEVICE. THE PROCEDURE WAS INITIALLY PERFORMED VIA THE RADIAL APPROACH. THE LESION WAS PRE-DILATED USING A 2.5X15 SEMI-COMPLIANT BALLOON AND A 4.0X12 SHOCKWAVE BALLOON, WITH MULTIPLE BALLOON INFLATIONS PERFORMED. AN INITIAL ATTEMPT TO DELIVER THE 3.0X26 STENT WAS UNSUCCESSFUL AS THE STENT DID NOT CROSS THE LESION. A GUIDELINER WAS USED AND THE STENT WOULD STILL NOT CROSS THE LESION. UPON REMOVAL OF THE STENT BALLOON, IT WAS OBSERVED THAT THE 3.0X26 STENT WAS NO LONGER ATTACHED TO THE BALLOON CATHETER. THE DISLODGED STENT WAS SNARED AND REMAINED IN THE RIGHT BRACHIAL ARTERY AS THE STENT WOULD NOT GO PAST THIS POINT. THE PHYSICIAN THEN SWITCHED TO A GROIN APPROACH, USING AN NC 3.5X27 BALLOON AT THE TARGET LESION AND A 7 FRENCH GUIDELINER. AN ATT

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

  MAUDE report 24517710 ↗
• MalfunctionJan 9, 2025Difficult to Insert; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Material Deformation; Difficult to Insert; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT DURING THE DELIVERY OF AN ONYX FRONTIER CORONARY DRUG ELUTING STENT THE DELIVERY SYSTEM DETACHED/FRACTURED. THE INTENDED LESION WAS THE LEFT ANTERIOR DESCENDING (LAD) ARTERY, THE DETACHED PORTION OF THE DEVICE DOES NOT REMAIN IN THE PATIENT AS THE FRACTURED SECTION WAS OUTSIDE OF THE PATIENT. THE CATHETER/DELIVERY SYSTEM DEFORMED AND A KINK WAS NOTED. IT WAS STATED THATTHERE WERE WIRES IN THE LAD AND DIAGONAL FOR POSSIBLE DOUBLE KISS CRUSH TECHNIQUE. ONE STENT WAS POSITIONED IN THE DIAGONAL AND AN ATTEMPT WAS MADE TO POSITION THE OTHER STENT IN THE LAD WHEN RESISTANCE WAS MET AND THE STENT DELIVERY SYSTEM SEVERED. IT WAS DISCOVERED THAT THE STENT INTENDED FOR THE LAD WAS PUT ON THE DIAGONAL WIRE WHICH IS WHY THERE WAS RESISTANCE. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE PATIENT WAS REPORTED ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21112060 ↗
• MalfunctionJul 12, 2024Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A SEVERELY TORTUOUS, MODERATELY CALCIFIED LESION WITH 80% STENOSIS IN THE MID CIRCUMFLEX (CX) ARTERY. 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 NOT NOTED WHILE ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. IT WAS FURTHER REPORTED THAT A STENT STRUT FLARE OCCURRED WHEN UNDEPLOYED STENT WAS REMOVED THROUGH THE GUIDE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER 3.0 X 30MM ONYX FRONTIER DEVICE. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19735430 ↗
• InjuryApr 17, 2024Device Dislodged or Dislocated; Material Deformation; Positioning Problem; Device Dislodged or Dislocated; Material Deformation; Positioning Problem

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT (DES) TO TREAT A SEVERELY CALCIFIED LESION LOCATED IN THE O STIUM/PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY AND LEFT MAIN (LM) CORONARY ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES. 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 DELIVERY TO THE LESION. IT WAS STATED THAT THE STENT BECAME DISLODGED IN THE CALCIFIED LEFT MAIN. THE PATIENT WENT TO SURGERY TO GET THE STENT OUT THE NEXT DAY, AND ALSO HAD AN OPEN HEART BYPASS. THE DISLODGED STENT WAS REMOVED. THE PATIENT IS ALIVE AND STABLE WITH NO FURTHER INJURY REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19123144 ↗
• MalfunctionFeb 19, 2024Material Deformation; Positioning Problem; Material Deformation; Positioning Problem

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG-ELUTING STENT TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS LESION WITH 90% 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. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT THE DEVICE FAILED TO CROSS THE LESION. IT WAS DETAILED THAT WHEN THE STENT WAS REMOVED FROM THE PATIENT, IT WAS NOTED THAT THE MID-STRUT WAS ELEVATED. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18735551 ↗
• MalfunctionFeb 9, 2024Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG-ELUTING STENT TO TREAT A MILDLY TORTUOUS, SEVERELY CALCIFIED LESION WITH 100% CHRONIC TOTAL OCCLUSION (CTO) IN THE OSTIUM OF THE RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. 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 WHILE ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. 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 18679803 ↗
• MalfunctionNov 7, 2023Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER DRUG ELUTING STENT (DES) TO TREAT A NON-TORTUOUS, SEVERELY CALCIFIED LESION IN THE MID RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED WITH MULTIPLE NC BALLOONS. 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 DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. IT WAS DETAILED THAT A DEFORMED STENT STRUT WAS NOTED WHEN THE DEVICE WAS REMOVED FROM THE PATIENT. IT WAS BELIEVED THAT THE DEFORMATION WAS MOST LIKELY FROM THE CALCIFIED VESSEL. THE LESION WAS BALLOONED FURTHER WITH 3.0 SHOCKWAVE. A 3.00X30MM ONYX FRONTIER WAS THEN SUCCESSFULLY DEPLOYED. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18084724 ↗
• InjuryOct 11, 2023Burst Container or Vessel; Deflation Problem; Difficult to Remove; Material Deformation; Burst Container or Vessel; Deflation Problem; Difficult to Remove; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG-ELUTING STENT TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 90% STENOSIS IN THE CIRCUMFLEX (CX) ARTERY. 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 THE DELIVERY. IT WAS REPORTED THAT BALLOON DEFLATION DIFFICULTIES OCCURRED, THE DEVICE WOULD NOT DEFLATE AT THE LESION SITE. IT WAS DETAILED THAT THE BALLOON WAS BURST WITH THE BACK OF A CORONARY WIRE. THE BALLOON WAS SAFELY REMOVED WITH NO ISSUES. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information

  MAUDE report 17911905 ↗
• DeathAug 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ATTEMPT WAS MADE TO USE ONE NC EUPHORA CORONARY BALLOON CATHETER TO TREAT A SEVERELY CALCIFIED, MODERATELY TORTUOUS LESION WITH 90-95% STENOSIS IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS NOT PRE-DILATED. THE DEVICE WAS BEING USED TO PRE-DILATE THE LESION. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT A BALLOON BURST OCCURRED AT 16 ATM DURING BALLOON INFLATION. IT WAS DETAILED THAT THE BALLOON WAS DELIVERED TO THE SITE OF THE HEAVY CALCIFIED LESION IN THE PROXIMAL LAD. AFTER THE FIRST INFLATION THE BALLOON RUPTURED AND BECAME CAUGHT OR HUNG UP AT THE LESION SITE OF INFLATION. THE DEVICE WAS NOT MOVED OR REPOSITIONED WHILE INFLATED. THERE WERE REMOVAL DIFFICULTIES AS THE BALLOON APPEARED TO BE CAUGHT ON THE CALCIUM, DESPITE SEVERAL ATTEMPT TO PULL THE CATHETER DELIVERY SYSTEM AND BALLOON BACK INTO THE GUIDE CATHETER. DUE TO 8/10 CHEST PAIN, A BALLOON PUMP WAS INSERTED, WITH IMPROVEMENT IN CHEST PAIN TO 4/10. THE PATIENT REMAINED HEMODYNAMICALLY STAB

  Patient problems: Insufficient Information

  MAUDE report 17562534 ↗
• MalfunctionMay 16, 2023Material Deformation; Positioning Problem; Material Deformation; Positioning Problem

  AN ATTEMPT WAS MADE TO USE TWO ONYX FRONTIERS TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION WITH 85% STENOSIS IN THE MID RIGHT CORONARY ARTERY (RCA). THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED ON THE DEVICES. THE DEVICES WERE NOT PASSED THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICES. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT THE LESION. INITIALLY, THE 2.75X22MM STENT WAS ATTEMPTED TO BE DELIVERED TO THE MID TO DISTAL RCA WITHOUT PRE-DILATION. HOWEVER, IT WAS UNABLE TO CROSS AND RESISTANCE WAS FELT, SO IT WAS TAKEN OUT OF THE BODY. A BALLOON WAS USED TO PRE-DILATE THE LESION WITH NO ISSUES NOTED. THE 2.75X22MM STENT WAS ADVANCED AGAIN AND DELIVERED TO THE LESION. HOWEVER THE STENT FELL OFF THE BALLOON AND BECAME DISLODGED IN THE VESSEL. DIFFERENT TECHNIQUES WERE USED TO TACK THE DISLODGED STENT TO THE VESSEL WALL INCLUDING USING A 3.00X26MM STENT WITHOUT ANY SUCCESS. IT WAS REPORTED THAT THE 3.00X26MM STENT FAILED TO CROSS/POSITION THE LESION. FOLLOWING REMOVAL OF THE 3.00X26MM STENT IT WAS NOTICED THE A STENT STRU

  Patient problems: Insufficient Information

  MAUDE report 16940248 ↗
• InjuryApr 11, 2023Device Damaged by Another Device; Device Damaged by Another Device

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED LESION WITH 70-80% STENOSIS IN THE OSTIUM OF THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PREDILATED WITH A 2.25 BALLOON. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. RESISTANCE WAS NOTED DURING WITHDRAWAL OF THE DEVICE AND EXCESSIVE FORCE WAS USED. THE DEVICE WAS NOT KINKED AND RE-STRAIGHTENED DURING USE. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT THE LESION. THE STENT BECAME STUCK IN A 3.0 X 26 ONYX FRONTIER STENT (PLI20)WHICH HAD BEEN PREVIOUSLY IMPLANTED IN THE CIRCUMFLEX INTO THE LEFT MAIN. THE STENT WOULD NOT ADVANCE OR COME BACK. THIS CAUSED THE STENT TO DISLODGE. RESISTANCE WAS NOTED DURING WITHDRAWAL OF THE DEVICE AND EXCESSIVE FORCE WAS USED. WHEN IT WAS ATTEMPTED TO EXTRACT THE DISLODGED DEVICE, THE STENT BROKE. THE DETACHED PORTION WAS EXTRACTED SEPARATELY. EVERYTHING WAS REMOVED VIA A SNARE. NO DAMAGE WAS

  Patient problems: Insufficient Information

  MAUDE report 16714647 ↗