Onyx Frontier™ ONYXNG20015UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00763000511135), received between Oct 12, 2022 and Jun 12, 2026 — classified as 7 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (10 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2026Device Dislodged or Dislocated; Positioning Problem

  DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT WHEN STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE LESION BEING TREATED WAS A MILDLY TORTUOUS, MODERATELY CALCIFIED LESION WITH 90% STENOSIS LOCATED IN THE MID-PROXIMAL CIRCUMFLEX (CX) ARTERY AND OBTUSE MARGINAL (OM). A 2.5 X 12 MM COMPLIANT BALLOON WAS USED, FOLLOWED BY A NON-MEDTRONIC CUTTING BALLOON IN THE MID LCX ARTERY. A NON-MEDTRONIC 3.0 X 32 MM DES WAS PLACED AND POST-DILATED WITH A 3.5 MM NC BALLOON. THE OM1 SHOWED A MODERATE LESION AND WAS TREATED WITH ANGIOPLASTY. THE PATIENT COMPLAINED OF CHEST PAIN 2 HOURS LATER AND WAS TAKEN BACK FOR A RELOOK, AND WAS FOUND TO HAVE STENT THROMBOSIS. INTRAVASCULAR ULTRASOUND (IVUS) SHOWED CALCIUM AND THROMBUS. CORONARY THROMBECTOMY WAS PERFORMED ON THE PATIENT FOLLOWED BY CORONARY 3.0 SHOCKWAVE INTRAVASCULAR LITHOTRIPSY (IVL). AN ATTEMPT WAS MADE TO PLACE A NON-MEDTRONIC 2.25 MM DES IN OM1. THE STENT WAS REMOVED UNDEPLOYED. A 2.0 MM NC BALLOON WAS USED IN THE OM1. A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25483521 ↗
• MalfunctionMay 28, 2026Device Dislodged or Dislocated; Material Deformation; Positioning Problem

  ONE ONYX FRONTIER CORONARY DRUG ELUTING DELIVERY SYSTEM WAS RETURNED TO MEDTRONIC WITH A DISLODGED STENT RECEIVED ALONGSIDE. DEFORMATION WAS EVIDENT TO THE DISLODGED STENT. IT WAS REPORTED AND CONFIRMED BY THE ACCOUNT THAT THE STENT FAILED TO CROSS THE LESION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25314889 ↗
• MalfunctionMay 21, 2026Use of Device Problem

  IT WAS REPORTED THAT ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT WAS EXPIRED BY APPROXIMATELY 10 DAYS WHEN IMPLANTED IN THE PATIENT. 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 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. THE LESION BEING TREATED WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25239393 ↗
• InjuryMar 24, 2026Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE ONE EUPHORA RX CORONARY BALLOON AND ONE 2.0 X 15 MM ONYX DRUG ELUTING STENT WERE USED. THE TARGET LESION WAS LOCATED IN THE OSTIUM OF THE CIRCUMFLEX (CX) AND OBTUSE MARGINAL (OM) WHICH EXHIBITED NO TORTUOSITY AND NO CALCIFICATION. 30-40% LESION STENOSIS WAS PRESENT IN THE OSTIAL CX AND 80% LESION STENOSIS WAS PRESENT IN THE OM. NO ISSUES WERE NOTED ON THE DEVICES PRIOR TO USE. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED WITH THE EUPHORA BALLOON WITH NO ISSUES. RESISTANCE WAS NOT ENCOUNTERED WHILE ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE BALLOON BURST WHEN INFLATED TO NOMINAL PRESSURE. AFTER REMOVAL OF THE BALLOON, IMAGING WAS PERFORMED TO ASSESS THE VESSEL AND CONTRAST DYE STATUS, WHICH INITIALLY MADE THE VESSEL APPEAR TO BE DISSECTED. THE PHYSICIAN TOOK ANOTHER PICTURE AFTER BALLOON REMOVAL, AND THE CONTRAST DYE WAS GONE. THE BALLOON WAS EVALUATED OUTSIDE THE BODY AND DEMONSTRATED A RUPTURED BALLOON. THE ONYX DEVICE FAILED TO CROSS THE LESION. THE PATIENT WAS ASYMPTOMATIC AND THERE APPEARED TO BE NO EXTRAVASATION. BEDSIDE ECHO REVEALED NO PERICARDIAL EFFUSION. GIVEN THE PATIE

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

  MAUDE report 24679986 ↗
• InjuryOct 31, 2025Device Damaged by Another Device; Device Dislodged or Dislocated; Material Deformation; Positioning Problem; Device Damaged by Another Device; Device Dislodged or Dislocated; Material Deformation; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT DISLODGED DURING DELIVERY TO OR AT THE LESION LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE PATIENT HAD A PREVIOUS ONYX STENT IMPLANTED IN THE LAD ARTERY SEVERAL MONTHS AGO AND RETURNED WITH CHEST PAIN. NO IMAGING WAS PERFORMED FOLLOWING THE ORIGINAL STENT PLACEMENT. AN ATTEMPTED WAS MADE TO TREAT A DISEASE DISTAL TO THE PREVIOUSLY PLACED STENT USING THE 2.0X15MM ONYX FRONTIER STENT. THE DEVICE PASSED THROUGH THE PREVIOUSLY DEPLOYED STENT WHICH WAS BELIEVED TO BE UNDER EXPANDED AND MALPOSED DISTALLY. RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE DEVICE. APPROXIMATELY SEVEN HOURS OF UNSUCCESSFUL ATTEMPTS TO RETRIEVE THE DISLODGED STENT WERE MADE INVOLVING INTERVENTIONAL RADIOLOGY (IR) AND MULTIPLE INTERVENTIONAL CARDIOLOGISTS (IS). IT WAS STATED THAT A SNARE COULD NOT BE USED. THE DISLODGED STENT REMAINS IN THE PATIENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23439788 ↗
• MalfunctionApr 28, 2025Device Dislodged or Dislocated; Material Deformation; Positioning Problem; Device Dislodged or Dislocated; Material Deformation; Positioning Problem

  IT WAS REPORTED THAT AN ONYX FRONTIER STENT DISLODGED FROM THE BALLOON DURING REMOVAL FOLLOWING A FAILED DELIVERY AS IT EXITED A 5.5 GUIDE EXTENSION CATHETER DEVICE (GEC) AND ENTERED THE PROXIMAL DIAGONAL BRANCH. THE STENT BECAME TRAPPED AND WAS PULLED BACK INTO THE GEC DEVICE AND EVERYTHING WAS REMOVED. THE LESION BEING TREATED WAS MODERATELY CALCIFIED IN THE PROXIMAL DIAGONAL BRANCH. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21916580 ↗
• MalfunctionApr 25, 2025Device Dislodged or Dislocated; Material Deformation; Positioning Problem; Device Dislodged or Dislocated; Material Deformation; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT, THE STENT WAS UNABLE TO CROSS THE LESION. THE LESION BEING TREATED WAS MILDLY TORTUOUS, MODERATELY CALCIFIED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES. THE LESION WAS PRE-DILATED AND WAS PRE-TREATED WITH A LASER. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. AFTER FAILING TO CROSS THE LESION THE STENT WAS TAKEN OUT UNDEPLOYED. THE LESION WAS FURTHER TREATED WITH BALLOON ANGIOPLASTY BEFORE INSERTING THE STENT AGAIN, WHEN IT WAS NOTED THAT THE BALLOON/CATHETER APPEARED DAMAGED. IT WAS ALSO STATED THAT THE STENT HAD DAMAGE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21908142 ↗
• InjuryFeb 14, 2025Device Dislodged or Dislocated; Positioning Problem; Device Dislodged or Dislocated; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING AN ONYX FRONTIER DRUG ELUTING STENT, STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT THE LESION. THE STENT STRIPPED OF THE CATHETER. IT WAS ATTEMPTED TO REMOVE THE DISLODGED STENT WITH A SNARE BUT THE DISLODGED STENT WAS UNABLE TO BE REMOVED AND REMAINS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 21384081 ↗
• InjuryNov 29, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT PRESENTED WITH SUDDEN ONSET OF CHEST PAIN AND SHORTNESS OF BREATH. IT WAS REPORTED THAT DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT LESIONS IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) AND DISTAL RCA AND STENT DISLODGEMENT OCCURRED. IT WAS DETAILED THAT THE STENT WAS MISSING AND THE PHYSICIAN TRIED A WIRE TECHNIQUE TO FIND AND REMOVE THE STENT. THE STENT FLOATED TO THE PROXIMAL RIGHT CORONARY ARTERY (RCA) AND DUE TO MULTIPLE WIRES USED DURING THE PROCEDURE A SPIRAL CORONARY DISSECTION OCCURRED. THE STENT WAS ABANDONED. THE PATIENT ENDED UP HAVING 6 STENTS IMPLANTED IN THE WHOLE RCA. A FALSE LUMEN WAS INTENTIONALLY STENTED UP TO THE MID VESSEL WHERE IT WAS POSSIBLE TO RE ENTER INTO THE TRUE LUMEN AND CONNECT TRUE LUMEN TO TRUE LUMEN DISTALLY. THE SPIRAL DISSECTION DID RESULT IN LOSS OF AN ACUTE MARGINAL LATERAL BRANCH, WHICH RESULTED IN SOME LIKELY CHEST DISCOMFORT AND ABNORMAL EKG. NO FURTHER PATIENT INJURY OCCURRED.

  Patient problems: Chest Pain; Device Embedded In Tissue or Plaque; Insufficient Information; Non specific EKG/ECG Changes; Obstruction/Occlusion; Vascular Dissection

  MAUDE report 20809823 ↗
• MalfunctionOct 4, 2024Material Deformation; Positioning Problem; Material Deformation; Positioning Problem

  AN ATTEMPT WAS MADE TO USE TWO ONYX FRONTIER CORONARY DRUG ELUTING STENTS TO TREAT A MILDLY TORTUOUS, SEVERELY CALCIFIED LESION IN THE MID OBTUSE MARGINAL (OM). THE DEVICES WERE INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED ON BOTH DEVICES WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOTED WHILE ADVANCING BOTH DEVICES. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT FOR BOTH DEVICES. IT WAS DETAILED THAT BOTH DEVICES COULD NOT CROSS THE LESION, AND ABNORMAL DAMAGE WAS VISUALIZED UPON REMOVAL. THE DAMAGE TO STENT STRUTS WHICH OCCURRED AFTER FAILURE TO CROSS WAS ATYPICAL. THE PROCEDURE WAS NOT COMPLETED. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20366337 ↗
• MalfunctionJul 4, 2024Material Deformation; Positioning Problem; Material Deformation; Positioning Problem

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION IN THE MID CIRCUMFLEX (CX) 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 DELIVERY. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. THE LESION IN THE CX WAS PRE-DILATED WITH A 1.5MM BALLOON AND AS IT WAS VERY TORTUOUS AND CALCIFIED, IT WAS NECESSARY TO USE A TELESCOPE GUIDE EXTENSION CATHETER. IT WAS ATTEMPTED TO CROSS THE LESION A FEW TIMES WITH THE STENT BUT IT RAN INTO CALCIUM. THE STENT WAS TAKEN OUT AND IT WAS THEN NOTED THAT A STENT STRUT WAS RAISED DUE TO THE CALCIUM IN THE STENT. IT WAS BELIEVED THAT THE STENT GOT CAUGHT UP ON THE CALCIUM. THE PROCEDURE WAS COMPLETED USING A 2.25 X 15MM ONYX FRONTIER STENT. THE PATIENT WAS REPORTED TO BE FINE. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19674253 ↗
• InjuryOct 24, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG-ELUTING STENT DURING A PROCEDURE TO TREAT A MILDLY TORTUOUS, SEVERELY CALCIFIED LESION WITH 99% STENOSIS IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) 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. EXCESSIVE FORCE WAS NOT USED DURING THE DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT THE LESION. THE DISLODGED STENT WAS NOT REMOVED. IT WAS DETAILED THAT A NON-MEDTRONIC BALLOON WAS INSERTED OVER THE WIRE AND THE STENT WAS SUCCESSFULLY DEPLOYED IN THE LEFT MAIN (LM). INTRAVASCULAR ULTRASOUND (IVUS) WAS USED TO ASSESS THE VASCULATURE. THE STENT WAS POST-DILATED WITH A 4.0MM NC BALLOON AND A 4.5MM NC BALLOON. THE RESULT WAS IMPROVED TIMI-3 FLOW. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

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

  MAUDE report 17993716 ↗
• InjuryApr 26, 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 WITH 80% STENOSIS, LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. THE DEVICE DID 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 DELIVERY TO THE LESION. AN ATTEMPT WAS BEING MADE TO ADVANCE THE DEVICE TO THE MID RCA WHEN THE STENT STRIPPED OFF THE BALLOON AT THE OSTIAL RCA. THE STENT WAS CRUSHED TO THE VESSEL WALL AND A NON-MEDTRONIC DEVICE WAS PLACED AT THE SITE. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information

  MAUDE report 16813435 ↗
• MalfunctionApr 21, 2023Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS, MODERATELY CALCIFIED LESION WITH 90% STENOSIS IN THE PROXIMAL OBTUSE MARGINAL (OM) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED WITH A 2.0 X 10MM EUPHORA BALLOON. 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 A BALLOON LEAK OCCURRED DURING STENT DEPLOYMENT. AFTER THE VESSEL WAS PRE-DILATED, IVUS WAS PERFORMED WHICH CONFIRMED THE VESSEL SIZE AND THE LESION WAS THEN STENTED THE ONYX FRONTIER STENT. IT WAS NOTED THAT THE BALLOON WOULD NOT STAY AT 14ATM WITHOUT ADDED PRESSURE. TWO INFLATIONS HAD BEEN PERFORMED PRIOR TO THE ISSUE OCCURRING. WHEN THE DEVICE WAS REMOVED AFTER THE STENT WAS ADEQUATELY DEPLOYED, IT WAS INSPECTED AND BLOOD WAS OBSERVED IN THE BALLOON. IT WAS SUSPECTED THAT THERE MAY HAVE BEEN A SMALL LEAK IN THE BALLOON. THE PATIENT EXPERIENCED NO HARM AND THE STENT WAS DEPLOYED SUCCESSFULLY. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16784547 ↗
• InjuryOct 12, 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 TORTUOUS, SEVERELY CALCIFIED LESION IN THE PROXIMAL DIAGONAL BRANCH. 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. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION. THE STENT CAME OFF/DISLODGED OFF OF THE BALLOON BEFORE DEPLOYMENT. THE STENT WAS REMOVED FROM THE PATIENT USING A SNARE. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15585998 ↗