Onyx Frontier™ ONYXNG20012UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00763000511128), received between Sep 12, 2022 and Apr 22, 2026 — classified as 6 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (9 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.

• MalfunctionApr 22, 2026Deformation Due to Compressive Stress; Device Dislodged or Dislocated; Material Deformation; Positioning Problem

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT WHEN STENT DISLODGMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. THE LESION BEING TREATED WAS A CALCIFIED LESION LOCATED IN THE THE OBTUSE MARGINAL (OM) ARTERY. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. A NON-MEDTRONIC GUIDEWIRE AND GUIDE CATHETER WERE USED DURING THE PROCEDURE. THE LESION WAS PREDILATED USING A 2.0 X 12MM NON-MEDTRONIC BALLOON INITIALLY PRESSURISED TO 10 ATM THEN TO 14ATM. AN ATTEMPT WAS MADE TO POSITION THE ONYX FRONTIER STENT IN THE ARTERY AFTER PRE-DILATION BUT IT WAS UNABLE TO CROSS. THE STENT WAS REMOVED. A NON-MEDTRONIC GUIDE EXTENSION CATHETER WAS USED AND THE ONYX FRONTIER STENT WAS ATTEMPTED TO BE USED AGAIN, HOWEVER IT FAILED TO CROSS. BALLOON DILATION WAS ATTEMPTED AGAIN AND THE ONYX FROMTIER STENT WAS ATTEMPTED TO CROSS AFTER DILATION HOWEVER, IT DIDN'T CROSS AND THE STENT DISLODGED AND COMPLETELY FELL OFF WHEN PULLING THE STENT OUT OF THE GUIDE CATHETER. A NON-MEDTRONIC 2.25 X13MM STENT WAS ATTEMPTED TO BE U SEDAND WAS SUCC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24951328 ↗
• MalfunctionOct 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING DELIVERY OF ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO OR AT THE LESION, STENT DISLODGEMENT OCCURRED. THE DEVICE WAS INSPECTED PRIOR TO USE AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE STENT DISLODGED AT THE LESION SITE LOCATED IN THE MID OBTUSE MARGINAL (OM) ARTERY WHICH EXHIBITED MILD TORTUOSITY AND MODERATE CALCIFICATION. IT WAS POSSIBLE TO RETRIEVE THE STENT BACK INTO THE GUIDE AND REMOVE THE ENTIRE SYSTEM AS A UNIT. THE LESION WAS PRE-DILATED WITH A 1.5X12MM EUPHORA BALLOON AND THEN WITH A 2.0X12MM EUPHORA BALLOON WITH FULL EXPANSION. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23423780 ↗
• MalfunctionSep 15, 2025Use of Device Problem; Positioning Problem; Use of Device Problem; Positioning Problem

  IT WAS REPORTED THAT THE SHELF LIFE OF ONE ONYX FRONTIER CORONARY DRUG-ELUTING STENT HAD BEEN EXCEEDED AND THE DEVICE FAILED TO CROSS OCCLUSION. THE DEVICE WAS USED INSIDE THE PATIENT. THERE WAS NO PATIENT INJURY OR MEDICAL/SURGICAL INTERVENTION AS A RESULT OF THE EVENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23049368 ↗
• InjuryJul 30, 2025Device Damaged by Another Device; Difficult to Advance; Device Dislodged or Dislocated; Device Damaged by Another Device; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG-ELUTING STENT, DIFFICULTIES WERE ENCOUNTERED ADVANCING THE DEVICE AND STENT DISLODGMENT OCCURRED. THE LESION BEING TREATED WAS MILDLY TORTUOUS AND NON-CALCIFIED LOCATED IN THE PROXIMAL DIAGONAL BRANCH OF THE LEFT ANTERIOR DESCENDING ARTERY(LAD) WITH 90% STENOSIS. THE LESION WAS PRE-DILATED. THE DEVICE WAS UNABLE TO CROSS A NON-MEDTRONIC STENT THAT HAD BEEN IMPLANTED THREE YEARS EARLIER IN THE LAD, AND THE STENT BECAME DISLODGED WHILE ADVANCING TOWARD THE DIAGONAL. IT WAS NOTED THAT CALCIFICATION WAS PRESENT PROXIMAL TO THE LOCATION OF THE NON-MEDTRONIC STENT. THE STENT WAS THEN BALLOONED AGAINST THE WALL OF THE LAD AND IT WAS ATTEMPTED UNSUCCESSFULLY TO DEPLOY A NON-MEDTRONIC STENT AGAINST IT. EVENTUALLY THE STENT WAS CRUSHED AGAINST THE LAD WALL. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. NO EXCESSIVE FORCE WAS USED DURING DELIVERY. THE DEVICE WAS INSPECTED PRIOR TO USE AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 22662787 ↗
• MalfunctionJul 3, 2025Material Deformation; Positioning Problem; Material Deformation; Positioning Problem

  IT WAS REPORTED THAT ONE ONYX FRONTIER DRUG ELUTING STENT DEFORMED DURING POSITIONING AND ADVANCEMENT OF THE STENT IN VIVO. THE LESION WAS SEVERELY CALCIFIED WITH 90% STENOSIS AND MODERATE TORTUOSITY LOCATED AT THE PROXIMAL OBTUSE MARGINAL ARTERY. THE DEVICE WAS INSPECTED PRIOR TO USE AND 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 DURING DEVICE ADVANCEMENT, BUT NO EXCESSIVE FORCE WAS USED. IT WAS DETAILED THAT THE STENT FAILED TO CROSS THE LESION. THE STENT WAS REMOVED, AND THE LESION WAS FURTHER PRE-DILATED WITH BALLOONING. UPON ATTEMPTING TO RE-INSERT THE DEVICE AND CROSS THE LESION, A BROKEN STENT STRUT WAS OBSERVED STICKING UP WHEN ATTEMPTING TO PUT THE STENT BACK ON THE WIRE. THE PROCEDURE WAS COMPLETED USING A 2.0X12MM ONYX STENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22392593 ↗
• InjuryApr 27, 2025Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE DELIVERY OF ONE ONYX FRONTIER CORONARY DRUG-ELUTING STENT TO THE LESION, THE STENT DISLODGED. THE LESION BEING TREATED WAS MILDLY TORTUOUS AND MILDLY CALCIFIED LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA). THE LESION WAS PRE-DILATED, THE DEVICE PASSED THROUGH A PREVIOUSLY-DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND NO EXCESSIVE FORCE WAS USED DURING DELIVERY. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE STENT WAS NOT REMOVED FROM THE PATIENT AND WAS CRUSHED AGAINST THE VESSEL WALL. 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 21915923 ↗
• InjuryJun 11, 2024Positioning Problem; Positioning Problem

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A LESION LOCATED IN THE 1ST DIAGONAL. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. IT WAS REPORTED THAT A DISSECTION OCCURRED THE DEVICE FAILED TO CROSS THE LESION. IT WAS ALSO REPORTED THAT A DISSECTION OCCURRED DURING ATTEMPT TO DELIVER THE STENT TO THE VESSEL. IT WAS STATED THAT THERE WAS A BIT OF A ACUTE ANGLE TO GET IN THE LESION AND THE DEVICE FAILED TO CROSS THE LESION. THE PATIENT IS ALIVE WITH NO FURTHER INJURY. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Vascular Dissection

  MAUDE report 19511121 ↗
• MalfunctionJun 5, 2024Device Dislodged or Dislocated; Positioning Problem; Device Dislodged or Dislocated; Positioning Problem

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS, MODERATELY CALCIFIED LESION WITH 80% STENOSIS IN THE DISTAL RIGHT CORONARY ARTERY (RCA-PDL). THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED MULTIPLE TIMES WITH 2.0X6MM AND 2.5X15MM NON-MEDTRONIC 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 DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. THE STENT WAS UNABLE TO CROSS THE LESION, AND AS THE STENT WAS BEING REMOVED FROM THE GUIDE IT DISLODGED FROM THE BALLOON AND PULLED OFF. THE TIP OF THE WIRE AND THE STENT REMAIN IN THE RIGHT RADIAL ARTERY. IT WAS DECIDED THAT SURGERY WAS NOT NEEDED AT THIS TIME. THE PATIENT IS ALIVE WITH NO INJURY.

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

  MAUDE report 19467417 ↗
• MalfunctionFeb 20, 2024Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG-ELUTING STENT TO TREAT A LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT A CATHETER LEAK OCCURRED DURING STENT DEPLOYMENT. IT WAS DETAILED THAT THERE WAS NO INFLATION PRESSURE AND THE STENT WOULD NOT INFLATE. THE STENT WAS REMOVED FROM THE PATIENT. AN ATTEMPT WAS MADE TO INFLATE OUTSIDE THE BODY AND CONTRAST WAS OBSERVED COMING OUT OF THE CATHETER. THE PATIENT IS ALIVE WITH INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18740344 ↗
• InjuryDec 5, 2023Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A LESION IN THE OBTUSE MARGINAL ARTERY (OM1), FOLLOWING A PLAIN OLD BALLOON ANGIOPLASTY (POBA) TO THAT LESION. IT WAS REPORTED THE STENT DISLODGMENT OCCURRED. IT WAS DETAILED THAT THE STENT WAS UNABLE TO ADVANCE TO THE OM1 LESION, AND AN ATTEMPT WAS MADE TO REMOVE THE UNDEPLOYED STENT. HOWEVER, THE STENT STRIPPED OFF THE CATHETER/BALLOON DELIVERY SYSTEM AND REMAINED IN THE PROXIMAL CIRCUMFLEX (CX) ARTERY. A 2.0X12MM NON-MEDTRONIC NC BALLOON WAS INSERTED INTO THE DISLODGED STENT AND USED TO DEPLOY THE STENT IN THE PROXIMAL CX. THE PATIENT REMAINED STABLE AND WAS NOT HARMED IN THE PROCESS. NO FURTHER PATIENT INJURY WAS REPORTED.

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

  MAUDE report 18264717 ↗
• InjuryMay 30, 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 CALCIFIED, MODERATELY TORTUOUS LESION IN THE PROXIMAL CIRCUMFLEX (CX) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED WITH A 2.0 X 12MM EUPHORA BALLOON. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS USED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. THE STENT HAD DIFFICULTY ADVANCING THROUGH A CALCIFIED 90 DEGREE BEND OR TURN INTO THE OBTUSE MARGINAL ARTERY (OM-1). THERE WAS CALCIUM/PLAQUE PRESENT AT THE OSTIUM. AFTER THE LESION WAS PRE-DILATED AN ATTEMPT WAS MADE TO PASS THE ONYX FRONTIER THROUGH THE LESION, BUT WITH NO SUCCESS. IT WAS DECIDED TO REMOVE THE STENT AND USE A SHORTER STENT INSTEAD. HOWEVER, DURING REMOVAL OF THE STENT BACK INTO THE PROXIMAL CX THE STENT CAME OFF THE BALLOON. A SMALL BALLOON WAS USED TO PASS THROUGH THE PROXIMAL END OF THE DISLODGED STENT AND POST DILATE THE STENT UNTIL IT WAS WELL OPPOSED IN THE CX VESSEL. THE PATIENT IS DESCRIBED AS WELL. THE PATIENT IS ALIVE WITH

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

  MAUDE report 17018506 ↗
• MalfunctionMar 24, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG-ELUTING STENT TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. 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. IT WAS REPORTED THAT THE STENT CAME OFF THE BALLOON INSIDE THE GUIDE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16611500 ↗
• InjurySep 12, 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. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. IT WAS REPORTED THAT STENT DISLODGEMENT/EMBOLIZATION OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. THE DISLODGED STENT WAS NOT REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED. THE PATIENT WAS REPORTED ALIVE TO BE WITH NO INJURY.

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

  MAUDE report 15401206 ↗