Onyx Frontier™ ONYXNG22522UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00763000511227), received between Oct 20, 2022 and Apr 23, 2026 — classified as 5 injuries, 6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2026

  STENT CAME OFF DELIVERY SYSTEM WITHOUT BEING DEPLOYED / RETRIEVED WITH SNARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24965493 ↗
• MalfunctionApr 20, 2026Difficult to Advance; Device Dislodged or Dislocated

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT WHEN THE STENT BECAME DISLODGED AT THE LESION SITE. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS NOT PRE-DILATED. THE LESION BEING TREATED WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). THE LESION HAD MILD TORTUOSITY AND MODERATE CALCIFICATION. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE PAST THE LESION. AN ATTEMPT WAS MADE TO PULL THE STENT BACK THROUGH THE LESION WHEN THE STENT BECAME DISLODGED AT THE LESION SITE. THE STENT REMAINS IN THE PATIENT. NO OTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 24925348 ↗
• InjuryMay 29, 2025Device Dislodged or Dislocated; Positioning Problem; Device Dislodged or Dislocated; Positioning Problem

  IT WAS REPORTED THAT ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT FELL OFF THE BALLOON. NO 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 22104459 ↗
• InjuryApr 25, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT DISLODGED DURING DELIVERY TO THE LESION. THE LESION BEING TREATED WAS SEVERELY CALCIFIED, MODERATELY TORTUOUS WITH 80% STENOSIS IN THE PROXIMAL DIAGONAL BRANCH. THE DEVICE WAS INSPECTED PRIOR TO USE 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 DETAILED THAT THERE WAS A SIGNIFICANT AMOUNT OF UNSEEN CALCIUM. THE DISLODGED STENT REMAINED ON THE GUIDEWIRE AND AN ATTEMPT TO THREAD ANOTHER BALLOON INSIDE WAS UNSUCCESSFUL. A SNARE WAS USED AND AFTER SOME TIME THE DISLODGED STENT WAS BROUGHT BACK INTO THE GUIDE AND REMOVED. THE PROCEDURE CONTINUED, AND THE VESSEL WAS STENTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21907075 ↗
• MalfunctionFeb 12, 2025Entrapment of Device; Difficult to Insert; Material Deformation; Entrapment of Device; Difficult to Insert; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE TWO ONYX FRONTIER CORONARY DRUG ELUTING STENTS WERE ATTEMPTED TO BE USED, AND ONE DEVICE COULD NOT BE ADVANCED OVER THE WIRE, WHILE THE OTHER DEVICE HAD A KINK IN THE CATHETER. THE DEVICES WERE BEING USED TO TREAT MODERATELY TORTUOUS, SEVERELY CALCIFIED LESIONS IN THE RIGHT CORONARY ARTERY (RCA) AND OBTUSE MARGINAL (OM). THE OM LESION WAS PRE-DILATED WITH A 2.5X15MM BALLOON. THE RCA WAS NOT PRE-DILATED. BOTH DEVICES WERE INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICES. EXCESSIVE FORCE WAS NOT USED. AN ATTEMPT WAS MADE TO DEPLOY THE 2.5X22MM ONYX FRONTIER STENT IN THE CALCIFIED RCA, BUT THE STENT WOULD NOT ADVANCE OVER THE NON-MEDTRONIC 0.014 190CM WIRE. IT WAS NOT DIFFICULT TO REMOVE THE PROTECTIVE SHEATH AND PACKAGING STYLETTE OF THE 2.5X22MM ONYX FRONTIER STENT. THE GUIDEWIRE LUMEN IN THE 2.5X22MM ONYX FRONTIER STENT DEVICE WAS FLUSHED BEFORE USE. THE GUIDEWIRE WAS EXAMINED AND FLUSHED BEFORE USE WITH NO ISSUES NOTED. THE GUIDEWIRE WAS BEING BACK LOADED THROUGH THE TIP. THE GUIDEWIRE HAD BEEN SUCCESSFULLY USED WITH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21364077 ↗
• MalfunctionJan 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 ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT FAILED TO DEPLOY. THE DEVICE WAS REMOVED IN ITS ENTIRETY WITH NO HARM TO THE PATIENT. UPON REMOVAL OF THE STENT DELIVERY SYSTEM FROM THE PATIENT¿S BODY IT WAS NOTED THAT THE STENT WAS LOOSE ON THE DELIVERY BALLOON. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED PRIOR TO USE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE DEVICE WAS NOT KINKED OR RE-STRAIGHTENED DURING USE. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21252413 ↗
• InjuryMay 20, 2024Difficult to Remove; Device Dislodged or Dislocated; Positioning Problem; Difficult to Remove; Device Dislodged or Dislocated; Positioning Problem

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. MULTIPLE ATTEMPTS WERE MADE UTILIZING MULTIPLE BALLOONS TO REMOVE THE UNDEPLOYED STENT. THE DISLODGED STENT WAS NOT REMOVED. IT WAS DECIDED TO DEPLOY THE STENT WHERE IT WAS IN THE PROXIMAL LAD TO REDUCE ANY HARM TO THE PATIENT. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

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

  MAUDE report 19350202 ↗
• InjuryMar 12, 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 HIGHLY TORTUOUS, MODERATELY CALCIFIED LESION WITH 80% STENOSIS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). 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 ENCOUNTEREDWHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION. THE RCA WAS ENGAGED WITH A NON-MEDTRONIC GUIDE EXTENSION CATHETER (GEC) FOR SUPPORT. AFTER PRE-DILATION THE STENT WAS ADVANCED BUT COULD NOT GET PAST THE TORTUOUS PROXIMAL SEGMENT. UPON RETRACTION, WITHOUT GEC INVOLVEMENT, THE BALLOON EASILY SLIPPED OUT OF THE UNDEPLOYED STENT. THERE WAS NO RESISTANCE NOTED DURING ATTEMPTED WITHDRAWAL OF THE DEVICE. THE STENT WAS LEFT IN THE PROXIMAL RCA. A 1.5MM NON-MEDTRONIC BALLOON WAS INSERTED IN THE STENT AND DILATED. THE STENT WAS SERIALLY DILATED WITH BIGGER BALLOONS UNTIL FULLY DEPLOYED. THEN THE DISTAL AND A PROXIMAL LESIONS WERE ABLE TO BE STENTED WITHOUT DIFFICULTY. IT IS BELIEVED THAT THE GEC WAS A CO NTRIBUTOR IN

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

  MAUDE report 18885308 ↗
• InjuryMar 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 TIGHT CALCIFIED LESION LOCATED IN THE MID CIRCUMFLEX (CX) ARTERY. BOTH THE PROXIMAL AND MID CX WERE DISEASED, AND THE PATIENT HAD CALCIFICATIONS IN THE LEFT ANTERIOR (LAD) DESCENDING ARTERY AND RIGHT CORONARY ARTERY (RCA). THE LESION WAS PRE-DILATED MULTIPLE TIMES WITH A BALLOON. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT THE LESION. THE STENT WAS MEANT TO BE DEPLOYED IN THE MID CX, BUT THE STENT DISLODGED OFF OF THE DELIVERY SYSTEM AND WAS SEEN IN THE PROXIMAL CX. IT WAS DETAILED THAT THE PATIENT MOVED, WHICH CAUSED THE WIRE TO COME OUT. IT WAS ALSO STATED THAT THE STENT DELIVERY SYSTEM WAS BEING MOVED AROUND AND THE STENT BECAME DISLODGED. AN ATTEMPT WAS MADE TO RE-WIRE THE VESSEL, BUT THIS WAS UNSUCCESSFUL. A GOOSENECK SNARE WAS ATTEMPTED TO RETRIEVE THE STENT, BUT WAS UNSUCCESSFUL BECAUSE THE WIRE CAME OUT. THE PATIENT WAS THEN REFERRED FOR 3-VESSEL CORONARY ARTERY (CABG) BYPASS GRAFT SURGERY, AND THE STENT WAS BYPASSED DURING CABG SURGERY. THE DISLODGED STENT REMAINS IN THE BODY IN THE LEFT CX ARTERY. THE PATIENT IS STILL IN HOSPITAL BUT IS DOING 'OK' POST CABG. THE

  Patient problems: Insufficient Information

  MAUDE report 16642500 ↗
• MalfunctionMar 28, 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 OSTIUM OF THE CIRCUMFLEX (CX) ARTERY. 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 ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS USED DURING DELIVERY. IT WAS REPORTED THAT FOLLOWING A FAILED DELIVERY TO THE LESION SITE, THE STENT DISLODGED INSIDE THE GUIDE CATHETER DURING REMOVAL. IT WAS DETAILED THAT THE DISLODGED STENT WAS REMOVED INSIDE THE GUIDE CATHETER. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16628134 ↗
• MalfunctionOct 20, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER DRUG ELUTING STENT (DES) TO TREAT A MODERATELY CALCIFIED, NON TORTUOUS LESION WITH 85% STENOSIS LOCATED IN THE PROXIMAL RAMUS ARTERY. THE DEVICE WAS INSPECTED WITH ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. RESISTANCE WAS NOT ENCOUNTERED WHEN REMOVING THE PROTECTIVE SHEATH. EXCESSIVE FORCE WAS NOT USED WHEN REMOVING THE PROTECTIVE SHEATH. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING SHEATH REMOVAL. THE DEVICE WAS INSERTED INSIDE THE PATIENT, HOWEVER, IT WAS DIFFICULT TO SEE THE STENT ON THE BALLOON. EFFORTS WERE MADE TO LOOK FOR THE STENT AND THE STENT WAS FOUND STUCK ON THE PLASTIC COVERING/SHEATH. THE STENT WAS NOT ON THE BALLOON INSIDE THE BODY. AN ATTEMPT WAS MADE TO INFLATE THE BALLOON WHILE IN THE PATIENT. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15638508 ↗