Onyx Frontier™ ONYXNG27522UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00763000511401), received between Jul 14, 2022 and Jul 30, 2026 — classified as 6 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (7 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2026Device Dislodged or Dislocated

  During a procedure an attempt was made to use one Onyx Frontier coronary Drug Eluting Stent when stent dislodgement occurred during delivery to/at lesion. The device was inspected with no issues. Negative prep was performed with no issues. The lesion was pre-dilated. There was no calcification present. The dislodged stent was removed with a snare. No further patient complications were reported as a result of the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50087877 ↗
• MalfunctionMay 5, 2026Deflation Problem

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT WHEN DEFLATION DIFFICULTIES WERE EXPERIENCED. THE DEVICE WOULD NOT DEFLATE AT THE LESION SITE. THE CATHETER AND STENT WERE REMOVED AND A DIFFERENT DEVICE WAS USED. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE LESION BEING TREATED WAS A MODERATELY TORTUOUS, MILDLY CALCIFIED LESION WITH 70% STENOSIS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE, AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25081119 ↗
• InjuryMar 24, 2026Device Damaged by Another Device; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT, STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT LESION. THE DEVICE WAS INSPECTED PRIOR TO USE AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DISLODGED STENT WAS NOT REMOVED AND THE PATIENT HAD TO UNDERGO SURGERY.  NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 24672722 ↗
• MalfunctionMar 18, 2026

  DELIVERY OF A 7 FRENCH GUIDE CATHETER EXTENSION INTO THE PROXIMAL RIGHT CORONARY ARTERY SEGMENT. SUBSEQUENT ATTEMPTS TO DELIVER A STENT WERE UNSUCCESSFUL. IN RETRIEVING THE ON DEPLOYED STENT, IT BECAME APPARENT THAT THE STENT STRIPPED OFF OF THE BALLOON LIKELY DUE TO AN INTERACTION BETWEEN THE PROXIMAL STENT EDGE AND THE GUIDE EXTENSION TIP. ATTEMPTS TO ADVANCE BALLOONS THROUGH THE UNINFLATED STENT, WHICH WAS TRAPPED ALONG THE OSTIUM OF THE RIGHT CORONARY ARTERY, WERE UNSUCCESSFUL. THEY WERE THEREAFTER ABLE TO GET FEMORAL ARTERY ACCESS AND SNARE THE STENT BUT ATTEMPTS TO REMOVE THE SNARED DISLODGED STENT WERE UNSUCCESSFUL, AND IT BECAME APPARENT THAT THE CORONARY ANGIOPLASTY WIRE WAS PINNED IN THE RIGHT CORONARY ARTERY. SURGEON ATTEMPTED TO FRAGMENT THE WIRE WITH A CUTTING BALLOON, BUT THIS PROVED UNSUCCESSFUL. SURGEON LASTLY ATTEMPTED TO CUT THE WIRE WITH A BIOPTOME DEVICE BUT WAS UNABLE TO MAKE CONTACT WITH THE WIRE FLOATING IN THE AORTA. FORTUNATELY, THE PATIENT REMAINED REMARKABLY STABLE. THE RIGHT CORONARY ARTERY REMAINED WIDELY PATENT, INCLUDING THE DISTAL ANGIOPLASTY SITE. AT THIS POINT, GIVEN THE INABILITY TO FREE THE PINNED WIRE THROUGH PERCUTANEOUS MEANS, CARDIOTHORACIC S

  Patient problems: Foreign Body In Patient

  MAUDE report 24625776 ↗
• MalfunctionDec 15, 2025Deformation Due to Compressive Stress; Difficult to Advance; Material Deformation; Positioning Problem; Deformation Due to Compressive Stress; Difficult to Advance; Material Deformation; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT, STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. IT WAS REPORTED THAT THE STENT WOULD NOT CROSS THE SEVERELY CALCIFIED LESION AND THE FRONT END OF THE STENT STRUT WAS PUSHED UP. AN ATTEMPT WAS MADE TO USE A 7F TELESCOPE GUIDE EXTENSION CATHETER BUT THE STENT WOULD NOT GO THROUGH. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT STENT, WHICH SUCCESSFULLY CROSSED THE LESION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23801219 ↗
• MalfunctionNov 4, 2025Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT DURING DELIVERY OF THE ONYX FRONTIER STENT TO A TIGHT LESION IN THE LEFT MAIN TO CIRCUMFLEX CORONARY ARTERY, THE STENT BECAME DISLODGED AND STRIPPED OFF THE BALLOON. THE DEVICE WAS INSPECTED PRIOR TO USE AND NEGATIVE PREP WAS PERFORMED, BOTH WITH NO ISSUES IDENTIFIED. THE DISLODGED STENT WAS REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 23468193 ↗
• InjuryJul 28, 2025Difficult to Remove; Device Dislodged or Dislocated; Material Deformation; Difficult to Remove; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE TWO ONYX FRONTIER CORONARY DRUG ELUTING STENTS DISLODGED DURING DELIVERY TO/AT THE LESION. THE LESION BEING TREATED WAS A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 95% STENOSIS LOCATED IN THE PROXIMAL LEFT MAIN (LM) CORONARY ARTERY/LEFT ANTERIOR DESCENDING (LAD) ARTERY. BOTH DEVICES WERE INSPECTED PRIOR TO USE AND NEGATIVE PREPPED WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE 2.50 X 12 MM ONYX FRONTIER STENT DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THIS DEVICE. IT WAS ATTEMPTED TO SNARE THE DISLODGED 2.75 X 22 MM ONYX FRONTIER STENT HOWEVER THIS WAS UNSUCCESSFUL. THE DISLODGED STENT WAS NOT REMOVED AND WAS THEN CRUSHED AND DEPLOYED IN THE VESSEL. THE DISLODGED 2.50 X 12 MM ONYX FRONTIER STENT WAS REMOVED USING A SNARE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22628496 ↗
• InjuryJan 9, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE ONYX FRONTIER STENT, MODERATELY TORTUOUS, SEVERE CALCIFICATION AND A 99% LESION STENOSIS WERE PRESENT IN THE RIGHT CORONARY ARTERY (RCA) AT THE OSTIUM. THE STENT DISLODGED DURING DELIVERY TO THE LESION AND WAS NOT REMOVED; INSTEAD, IT WAS STENTED AGAINST THE ARTERY WALL. THE DEVICE WAS INSPECTED WITH NO ISSUED NOTED. NEGATIVE PREP WAS NOT PERFORMED. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, AND EXCESSIVE FORCE WAS USED DURING DELIVERY. THE LESION WAS NOT PRE-DILATED, AND THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THE PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO FURTHER INJURY.

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

  MAUDE report 21110674 ↗
• MalfunctionApr 9, 2024Device Damaged by Another Device; Device Dislodged or Dislocated; Positioning Problem; Device Damaged by Another Device; Device Dislodged or Dislocated; Positioning Problem

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT (DES) TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED LESION WITH 90% STENOSIS IN THE PROXIMAL DIAGONAL. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS NOT 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 STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. IT WAS STATED THAT THE DISLODGED STENT CAME OUT AND WAS LOCATED IN THE TOUHEY. THE DISLODGED STENT WAS REMOVED. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19069059 ↗
• MalfunctionAug 28, 2023Detachment of Device or Device Component; Material Deformation; Positioning Problem; Detachment of Device or Device Component; Material Deformation; Positioning Problem

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG-ELUTING STENT TO TREAT A MODERATELY TORTUOUS, NON-CALCIFIED LESION WITH 80% STENOSIS IN THE MID LEFT ANTERIOR DESCENDING (LAD) 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 THE DELIVERY. IT WAS REPORTED THAT THE STENT FAILED TO CROSS THE LESION AND THE CATHETER OF THE STENT DETACHED DURING DELIVERY THROUGH THE VESSEL. THE DEVICE WAS NOT KINKED AND RE-STRAIGHTENED DURING USE. IT WAS DETAILED THAT THE STENT SHAFT BROKE BEFORE STENT DEPLOYMENT. THE UNIT WAS PULLED BACK WITH THE GUIDEWIRE INTO THE NON-MEDTRONIC GUIDE EXTENSION CATHETER. THE ENTIRE STENT SYSTEM INCLUDING THE DETACHED PORTION WAS REMOVED WITH NO COMPLICATIONS. IT WAS ALSO DETAILED THAT THE CASE WAS ABORTED AFTER THE EVENT. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17631111 ↗
• InjuryMay 16, 2023Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  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: Device Embedded In Tissue or Plaque

  MAUDE report 16940258 ↗
• InjuryJul 14, 2022Burst Container or Vessel; Inflation Problem; Difficult to Remove; Activation, Positioning or Separation Problem; Material Deformation; Positioning Problem; Burst Container or Vessel; Inflation Problem; Difficult to Remove; Activation, Positioning or Separation Problem; Material Deformation; Positioning Problem

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT (DES) TO TREAT, MODERATELY CALCIFIED, SEVERELY TORTUOUS LESIONS IN THE PROXIMAL AND DISTAL RIGHT CORONARY ARTERY (RCA). THE RIGHT CORONARY ARTERY (RCA) WAS DESCRIBED AS HAVING A SHEPARD'S CROOK AND A PREVIOUSLY IMPLANTED DES, WITH PROXIMAL AND DISTAL EDGE STENOSIS. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED WITH ONE 2.5X15MM NON-MDT BALLOON AND TWO 2.5X15MM SC EUPHORA BALLOON CATHETERS. THE ONYX FRONTIER DEVICE DID PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE ONYX FRONTIER DEVICE. EXCESSIVE FORCE WAS NOT USED. A 6FR LAUNCHER GUIDE CATHETER WAS ALSO USED. IT WAS REPORTED THAT DURING PRE-DILATION THE BALLOONS HAD DIFFICULTY CROSSING THE LESION. AFTER PRE-DILATION THE ONYX DEVICE WAS ADVANCED BUT FAILED TO CROSS THE PRE-EXISTING PROXIMAL DES AND WAS REMOVED. ADDITIONAL PRE-DILATIONS X3 WERE CARRIED OUT AND A 6FR NON-MDT GUIDE EXTENSION CATHETER WAS USED TO PASS THE ONYX FRONTIER TO THE POSTERIOR DESCENDING ARTERY (PDA). THE ONYX FRONTIER CROSSED THE LESION BUT ONLY 12MM OF THE 22MM LOOKED DEPLOYED IN TH

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions; Non specific EKG/ECG Changes

  MAUDE report 15011169 ↗