Onyx Frontier™ ONYXNG27530UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00763000511425), received between Oct 18, 2022 and Sep 29, 2026 — classified as 1 death, 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Positioning Problem” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Burst Container or Vessel; Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931820 ↗
• MalfunctionDec 22, 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 FAILED DELIVERY. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) WHICH EXHIBITED NO TORTUOSITY. THE DISLODGED STENT REMAINED PARTLY ON THE BALLOON, THEREFORE THE BALLOON WAS REMOVED FROM THE PATIENT WHILE ON THE BALLOON CATHETER. THE DEVICE WAS INSPECTED PRIOR TO USE 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 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 23861818 ↗
• DeathNov 13, 2025Device Damaged by Another Device; Adverse Event Without Identified Device or Use Problem; Device Damaged by Another Device; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS ADMITTED AND DIAGNOSED WITH INFERIOR STEMI. ATTEMPTS WERE MADE TO GAIN ACCESS VIA THE RIGHT RADIAL ARTERY HOWEVER DUE TO RESISTANCE WITH THE NON MEDTRONIC WIRE THIS WAS ABANDONED AND ATTEMPTS WERE THEN MADE TO ACCESS VIA THE RIGHT FEMORAL ARTERY. THE TARGET LESION WAS LOCATED IN THE MID/PROXIMAL RIGHT CORONARY ARTERY (RCA) WHICH EXHIBITED SEVERE CALCIFICATION AND MILD TORTUOSITY WITH 99% STENOSIS. THROMBUS WAS LIKELY IN THE MID SEGMENT. SUCCESSFUL BALLOON PRE DILATION WAS PERFORMED USING A 2.0X15MM EUPHORA BALLOON INFLATED MULTIPLE TIMES UP TO 16 ATM FOLLOWED BY 2.5X12 MM NC EUPHORA BALLOON INFLATED MULTIPLES TIMES UP TO 14 ATM. IT WAS NOTED DESPITE THE USE OF THE NON MEDTRONIC GUIDE EXTENSION CATHETERS (GEC) IT WAS DIFFICULT TO CROSS THE LESION WITH THE BALLOONS. A 2.75X32 MM ONYX FRONTIER DES WAS DEPLOYED IN THE MID RCA WITH THE ASSISTANCE OF THE NON-MEDTRONIC GEC, THE STENT WAS DEPLOYED FOR 16 AND 8 SECONDS AT 16ATM. IT WAS REPORTED THAT DURING USE OF ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT 3.0 X 22MM, STENT DISLODGEMENT OCCURRED IN THE MID RCA DURING REMOVAL FOLLOWING A FAILED DELIVERY AS IT WAS ASSESSED A DIFFERENT STENT SIZE MAY BE REQUIRED, IT WAS FELT

  Patient problems: Heart Block; Obstruction/Occlusion

  MAUDE report 23544331 ↗
• MalfunctionNov 1, 2024Burst Container or Vessel; Leak/Splash; Deformation Due to Compressive Stress; Positioning Problem; Burst Container or Vessel; Leak/Splash; Deformation Due to Compressive Stress; Positioning Problem

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE TWO ONYX FRONTIER CORONARY DRUG ELUTING STENTS TO TREAT A MODERATELY CALCIFIED LESION WITH 80% STENOSIS LOCATED IN THE PROXIMAL CIRCUMFLEX ARTERY. BOTH DEVICES WERE INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED ON THE DEVICES WITH NO ISSUES NOTED. THE LESION WAS PREDILATED. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE ONYX FRONTIER (LOT 0012293868) FAILED TO CROSS THE LESION AND THE STENT DEFORMED IN VIVO DURING POSITIONING/ADVANCEMENT. AFTER THE STENT FAILED TO CROSS THE LESION STRUT DEFORMATION WAS NOTED ONCE THE DEVICE WAS REMOVED FROM THE BODY. FOLLOWING THE FAILURE TO CROSS OF THE FIRST ONYX FRONTIER STENT, THE LESION WAS PREDILATED FOR A SECOND TIME. IT WAS REPORTED THAT A BURST OR A LEAK OCCURRED ON THE ONYX FRONTIER (LOT 0012316253) DURING NEGATIVE PREP AND PRIOR TO INSERTION INTO THE PATIENT. IT WAS STATED THAT THE STENT WAS INSERTED INTO THE PATIENT AND FAILED TO CROSS THE LESION, THE DEVICE WAS THEN REMOVED FROM BODY AND BLOOD RETURN WAS NOTED AT TIME OF REMOVAL. INFLATION OF THE DEVICE WAS NOT ATTEMPTED IN THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20586398 ↗
• MalfunctionNov 1, 2024Deformation Due to Compressive Stress; Material Deformation; Positioning Problem; Deformation Due to Compressive Stress; Material Deformation; Positioning Problem

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE TWO ONYX FRONTIER CORONARY DRUG ELUTING STENTS TO TREAT A MODERATELY CALCIFIED LESION WITH 80% STENOSIS LOCATED IN THE PROXIMAL CIRCUMFLEX ARTERY. BOTH DEVICES WERE INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED ON THE DEVICES WITH NO ISSUES NOTED. THE LESION WAS PREDILATED. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE ONYX FRONTIER (LOT 0012293868) FAILED TO CROSS THE LESION AND THE STENT DEFORMED IN VIVO DURING POSITIONING/ADVANCEMENT. AFTER THE STENT FAILED TO CROSS THE LESION STRUT DEFORMATION WAS NOTED ONCE THE DEVICE WAS REMOVED FROM THE BODY. FOLLOWING THE FAILURE TO CROSS OF THE FIRST ONYX FRONTIER STENT, THE LESION WAS PREDILATED FOR A SECOND TIME. IT WAS REPORTED THAT A BURST OR A LEAK OCCURRED ON THE ONYX FRONTIER (LOT 0012316253) DURING NEGATIVE PREP AND PRIOR TO INSERTION INTO THE PATIENT. IT WAS STATED THAT THE STENT WAS INSERTED INTO THE PATIENT AND FAILED TO CROSS THE LESION, THE DEVICE WAS THEN REMOVED FROM BODY AND BLOOD RETURN WAS NOTED AT TIME OF REMOVAL. INFLATION OF THE DEVICE WAS NOT ATTEMPTED IN THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20586386 ↗
• InjuryJan 30, 2024Entrapment of Device; Difficult to Remove; Device Dislodged or Dislocated; Material Deformation; Positioning Problem; Material Split, Cut or Torn; Entrapment of Device; Difficult to Remove; Device Dislodged or Dislocated; Material Deformation; Positioning Problem; Material Split, Cut or Torn

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION WITH 100% CHRONIC TOTAL OCCLUSION (CTO), LOCATED IN THE DISTAL CIRCUMFLEX (CX) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. 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. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. AN ATTEMPT WAS MADE TO DEPLOY THE STENT DISTAL TO TWO PREVIOUSLY DEPLOYED STENTS IN THE PROXIMAL AND OSTIAL CX ARTERY. AS THE STENT WAS ADVANCED RESISTANCE WAS MET IN THE PREVIOUSLY DEPLOYED STENTS. THE STENT WAS THEN ATTEMPTED TO BE PULLED BACK; HOWEVER, THIS WAS UNSUCCESSFUL. THE CATHETER WAS CUT AND A NON-MEDTRONIC GUIDE EXTENSION CATHETER WAS USED IN AN ATTEMPT TO RETRIEVE THE STENT. THE DELIVERY SYSTEM WAS THEN REMOVED; HOWEVER, THE STENT WAS STILL CAUGHT IN THE OSTIAL CX. A GOOSENECK SNARE WAS USED TO REMOVE THE DISLODGED STENT. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information

  MAUDE report 18606605 ↗
• InjuryJan 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A MILDLY CALCIFIED LESION 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 NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THE STENT WAS DEPLOYED IN THE MILDLY CALCIFIED LESION (NO INTRAVASCULAR ULTRASOUND [IVUS] WAS USED). IT WAS REPORTED THAT THE STENT WAS DEPLOYED AT 16 ATM FOR 42 SECONDS, AND THEN PERFORATION FOLLOWED. THE PATIENT WAS SENT TO AN OUTSIDE HOSPITAL FOR COVERED STENT PLACEMENT. NO FURTHER INJURY WAS REPORTED.

  Patient problems: Insufficient Information; Perforation

  MAUDE report 16213217 ↗
• MalfunctionOct 18, 2022Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT (DES) TO TREAT A SEVERELY TORTUOUS, MODERATELY CALCIFIED LESION WITH 90% STENOSIS IN THE PROXIMAL OBTUSE MARGINAL (OM). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PREFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED WITH A EUPHORA CORONARY BALLOON. A LAUNCHER GUIDE CATHETER WAS ALSO USED. 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 A STENT STRUT LIFTED ON CALCIUM. THE ONYX FRONTIER STENT FAILED TO CROSS THE DIFFICULT LESION EVEN AFTER PRE DILATION. THE STENT WAS PULLED OUT OF THE BODY IN ORDER TO PRE-DILATE THE LESION AGAIN, AND IT WAS NOTED THAT THE STENT STRUT WAS LIFTED. A DIFFERENT STENT WAS THEN USED TO COMPLETE THE PROCEDURE. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15623484 ↗