Onyx FrontierRecalls & reported problems across all models
Medtronic, Inc. · 71 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 627
- Deaths reported
- 18
- Injuries reported
- 308
- Recalls
- 0
We found 71 models of Onyx Frontier by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 627 adverse event reports in the FDA's MAUDE database, received between Jul 14, 2022 and Sep 29, 2026 — classified as 18 deaths, 308 injuries, 301 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (360 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Onyx Frontier problems
Device problems
- Device Dislodged or Dislocated360
- Material Deformation239
- Positioning Problem176
- Device Damaged by Another Device66
- Difficult to Remove58
- Detachment of Device or Device Component53
- Burst Container or Vessel39
- Deformation Due to Compressive Stress37
Patient problems
- No Clinical Signs, Symptoms or Conditions377
- Insufficient Information247
- Device Embedded In Tissue or Plaque127
- Vascular Dissection20
- Chest Pain15
- Myocardial Infarction15
- Obstruction/Occlusion15
- Thrombosis/Thrombus15
Onyx Frontier models
71 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Onyx Frontier™ ONYXNG25018UXCoronary drug-eluting stent2 deaths24 reports
- Onyx Frontier™ ONYXNG30038UXCoronary drug-eluting stent2 deaths23 reports
- Onyx Frontier™ ONYXNG25022UXCoronary drug-eluting stent21 reports
- Onyx Frontier™ ONYXNG20030UXCoronary drug-eluting stent19 reports
- Onyx Frontier™ ONYXNG25015UXCoronary drug-eluting stent2 deaths18 reports
- Onyx Frontier™ ONYXNG30022UXCoronary drug-eluting stent2 deaths18 reports
- Onyx Frontier™ ONYXNG25012UXCoronary drug-eluting stent17 reports
- Onyx Frontier™ ONYXNG20018UXCoronary drug-eluting stent16 reports
- Onyx Frontier™ ONYXNG20015UXCoronary drug-eluting stent15 reports
- Onyx Frontier™ ONYXNG35018UXCoronary drug-eluting stent15 reports
- Onyx Frontier™ ONYXNG20008UXCoronary drug-eluting stent14 reports
- Onyx Frontier™ ONYXNG25026UXCoronary drug-eluting stent1 death14 reports
- Onyx Frontier™ ONYXNG30012UXCoronary drug-eluting stent14 reports
- Onyx Frontier™ ONYXNG35022UXCoronary drug-eluting stent1 death14 reports
- Onyx Frontier™ ONYXNG20012UXCoronary drug-eluting stent13 reports
- Onyx Frontier™ ONYXNG22518UXCoronary drug-eluting stent13 reports
- Onyx Frontier™ ONYXNG25030UXCoronary drug-eluting stent13 reports
- Onyx Frontier™ ONYXNG35012UXCoronary drug-eluting stent13 reports
- Onyx Frontier™ ONYXNG22512UXCoronary drug-eluting stent12 reports
- Onyx Frontier™ ONYXNG22515UXCoronary drug-eluting stent12 reports
- Onyx Frontier™ ONYXNG22538UXCoronary drug-eluting stent12 reports
- Onyx Frontier™ ONYXNG27522UXCoronary drug-eluting stent12 reports
- Onyx Frontier™ ONYXNG30015UXCoronary drug-eluting stent12 reports
- Onyx Frontier™ ONYXNG30018UXCoronary drug-eluting stent1 death12 reports
- Onyx Frontier™ ONYXNG35015UXCoronary drug-eluting stent12 reports
- Onyx Frontier™ ONYXNG22522UXCoronary drug-eluting stent11 reports
- Onyx Frontier™ ONYXNG30026UXCoronary drug-eluting stent1 death11 reports
- Onyx Frontier™ ONYXNG35026UXCoronary drug-eluting stent11 reports
- Onyx Frontier™ ONYXNG35030UXCoronary drug-eluting stent11 reports
- Onyx Frontier™ ONYXNG35038UXCoronary drug-eluting stent11 reports
- Onyx Frontier™ ONYXNG25038UXCoronary drug-eluting stent10 reports
- Onyx Frontier™ ONYXNG20026UXCoronary drug-eluting stent9 reports
- Onyx Frontier™ ONYXNG27515UXCoronary drug-eluting stent1 death9 reports
- Onyx Frontier™ ONYXNG27518UXCoronary drug-eluting stent2 deaths9 reports
- Onyx Frontier™ ONYXNG30034UXCoronary drug-eluting stent9 reports
- Onyx Frontier™ ONYXNG22526UXCoronary drug-eluting stent8 reports
- Onyx Frontier™ ONYXNG25008UXCoronary drug-eluting stent8 reports
- Onyx Frontier™ ONYXNG25034UXCoronary drug-eluting stent8 reports
- Onyx Frontier™ ONYXNG27530UXCoronary drug-eluting stent1 death8 reports
- Onyx Frontier™ ONYXNG40018UXCoronary drug-eluting stent8 reports
- Onyx Frontier™ ONYXNG20022UXCoronary drug-eluting stent7 reports
- Onyx Frontier™ ONYXNG30008UXCoronary drug-eluting stent7 reports
- Onyx Frontier™ ONYXNG40022UXCoronary drug-eluting stent7 reports
- Onyx Frontier™ ONYXNG22508UXCoronary drug-eluting stent6 reports
- Onyx Frontier™ ONYXNG27512UXCoronary drug-eluting stent6 reports
- Onyx Frontier™ ONYXNG27534UXCoronary drug-eluting stent1 death5 reports
- Onyx Frontier™ ONYXNG27538UXCoronary drug-eluting stent5 reports
- Onyx Frontier™ ONYXNG30030UXCoronary drug-eluting stent5 reports
- Onyx Frontier™ ONYXNG35034UXCoronary drug-eluting stent5 reports
- Onyx Frontier™ ONYXNG40008UXCoronary drug-eluting stent1 death5 reports
- Onyx Frontier™ ONYXNG27526UXCoronary drug-eluting stent4 reports
- Onyx Frontier™ ONYXNG40012UXCoronary drug-eluting stent4 reports
- Onyx Frontier™ ONYXNG40030UXCoronary drug-eluting stent4 reports
- Onyx Frontier™ ONYXNG40038UXCoronary drug-eluting stent4 reports
- Onyx Frontier™ ONYXNG45012UXCoronary drug-eluting stent4 reports
- Onyx Frontier™ ONYXNG22530UXCoronary drug-eluting stent3 reports
- Onyx Frontier™ ONYXNG40015UXCoronary drug-eluting stent3 reports
- Onyx Frontier™ ONYXNG45022UXCoronary drug-eluting stent3 reports
- Onyx Frontier™ ONYXNG50012UXCoronary drug-eluting stent3 reports
- Onyx Frontier™ ONYXNG22534UXCoronary drug-eluting stent2 reports
- Onyx Frontier™ ONYXNG35008UXCoronary drug-eluting stent2 reports
- Onyx Frontier™ ONYXNG40026UXCoronary drug-eluting stent2 reports
- Onyx Frontier™ ONYXNG40034UXCoronary drug-eluting stent2 reports
- Onyx Frontier™ ONYXNG50018UXCoronary drug-eluting stent2 reports
- Onyx Frontier™ ONYXNG50030UXCoronary drug-eluting stent2 reports
- Onyx Frontier™ ONYXNG27508UXCoronary drug-eluting stent1 report
- Onyx Frontier™ ONYXNG45018UXCoronary drug-eluting stent1 report
- Onyx Frontier™ ONYXNG45026UXCoronary drug-eluting stent1 report
- Onyx Frontier™ ONYXNG45030UXCoronary drug-eluting stent1 report
- Onyx Frontier™ ONYXNG50015UXCoronary drug-eluting stent1 report
- Onyx Frontier™ ONYXNG50022UXCoronary drug-eluting stent1 report
Recent Onyx Frontier adverse event reports
The 15 most recent reports across all models, 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 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
A patient suffered from a heart attack and had 3 Onyx Frontier coronary drug eluting stents implanted. Approximately 3 months post procedure the three stents were occluded and the patient suffered from a heart attack. The stents had restenosis. The patient is awaiting a procedure to remove the plaque and open the lumen. No further patient complications were reported.
Patient problems: Myocardial Infarction; Obstruction/Occlusion; Restenosis
MAUDE report 50912136 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
A patient suffered from a heart attack and had 3 Onyx Frontier coronary drug eluting stents implanted. Approximately 3 months post procedure the three stents were occluded and the patient suffered from a heart attack. The stents had restenosis. The patient is awaiting a procedure to remove the plaque and open the lumen. No further patient complications were reported.
Patient problems: Myocardial Infarction; Obstruction/Occlusion; Restenosis
MAUDE report 50912131 ↗InjuryAug 7, 2026Device Dislodged or Dislocated; Positioning Problem
During a procedure an attempt was made to use one Onyx Frontier coronary Drug Eluting Stent when there was difficulties with the stent crossing a heavily calcified lesion and the stent come off the delivery system while trying to advance into the lesion. The stent was crushed to the side wall with good results. The procedure required atherectomy and multiple stents. No patient complications were reported as a result of the event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50175698 ↗InjuryAug 7, 2026Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated
During an attempt to place an Onyx Frontier coronary Drug Eluting Stent in a Left Anterior Descending Artery (LAD) lesion, the stent dislodged from the delivery balloon in the LAD. The dislodged stent required retrieval. The stent was trapped and crushed in the patient¿s femoral artery tissue with deployment of another covered stent. No further patient complications were reported as a result of the event.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 50174443 ↗InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem
During the index procedure one Prevail Drug coated balloon (DCB) was used to treat a lesion with 80% stenosis located in the 1st Diagonal artery. Two Onyx Frontier were also implanted in the 1st Diagonal during a second intervention on the same day post the index procedure. Approximately 1 month post the index procedure, the CEC adjudicated that the patient suffered from acute lesion thrombosis, ARC definite.
Patient problems: No Clinical Signs, Symptoms or Conditions; Thrombosis/Thrombus
MAUDE report 50170434 ↗InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem
During the index procedure one Prevail Drug coated balloon (DCB) was used to treat a lesion with 80% stenosis located in the 1st Diagonal artery. Two Onyx Frontier were also implanted in the 1st Diagonal during a second intervention on the same day post the index procedure. Approximately 1 month post the index procedure, the CEC adjudicated that the patient suffered from acute lesion thrombosis, ARC definite.
Patient problems: No Clinical Signs, Symptoms or Conditions; Thrombosis/Thrombus
MAUDE report 50170431 ↗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 ↗InjuryJul 30, 2026Device Dislodged or Dislocated; Positioning Problem
During a 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 not performed. The lesion was pre-dilated. The lesion being treated was a mildly tortuous, mildly calcified lesion located in the ostium of the Left Main (LM) Coronary Artery and Circumflex (CX) Artery. The device did pass through a previously-deployed stent. There was resistance encountered when advancing the device, and excessive force was not used during delivery. The stent was being delivered to the lesion site in the proximal CX artery when resistance was encountered. The stent was pulled out, and when it was pulled back it came off the balloon and got stuck in the patient in the LM and aorta. The stent was removed using a snare. No further patient complications were reported as a result of the event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50087362 ↗InjuryJul 30, 2026Device Dislodged or Dislocated; Positioning Problem
During a 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 not performed. The lesion was pre-dilated. The lesion being treated was a mildly tortuous, mildly calcified lesion with 80% stenosis located in the proximal Circumflex (CX) Artery. An attempt was made to deploy the stent in the proximal LCX when it came off the catheter. The stent and wire were pulled back into the guide, but the stent exited into the femoral sheath. It was snared down to the femoral artery and surgically removed. 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 further patient complications were reported as a result of the event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50086535 ↗InjuryJul 21, 2026Adverse Event Without Identified Device or Use Problem
DURING THE INDEX PROCEDURE ONE PREVAIL DRUG COATED BALLOON (DCB) WAS USED TO TREAT A LESION WITH 70% STENOSIS AND IN STENT RESTENOSIS (ISR) IN AN ONYX FRONTIER DRUG ELUTING STENT IN THE DISTAL RIGHT CORONARY ARTERY (RCA). THERE WERE MULTIPLE MEDTRONIC STENTS PLACED IN THE RCA ORIGINALLY APPROXIMATELY 12 MONTHS PREVIOUSLY FROM THE PROXIMAL RCA TO DISTAL RCA. THE AREA THAT WAS TREATED FOR ISR DURING THE INDEX PROCEDURE WAS THE DISTAL RCA. THE STENT IN THE DISTAL RCA WAS A 2.5X18MM ONYX FRONTIER STENT. APPROXIMATELY 6 MONTHS POST THE INDEX PROCEDURE THE PATIENT SUFFERED FROM CHEST PAIN/UNSTABLE ANGINA. WHEN THE PATIENT WAS SEEN IN CARDIOLOGY, THE PATIENT COMPLAINED OF WORSENING DYSPNEA ON EXERTION AND SPORADIC CHEST PAIN 1 TO 2 TIMES A DAY. DUE TO THE PATIENTS HISTORY OF IN STENT RESTENOSIS, THE PATIENT WAS SCHEDULED FOR A CATH. HOWEVER, THE PATIENT PRESENTED TO THE ER PRIOR TO THIS APPOINTMENT WITH 2 DAYS OF LEFT SIDED CHEST PRESSURE ASSOCIATED WITH LIGHT HEADEDNESS AND SHORTNESS OF BREATH WITH MINIMAL EXERTION. THE PATIENT WAS HOSPITALIZED. AN EKG PERFORMED FOUND 1ST DEGREE AV BLOCK WITH NO ST ELEVATION. TROPONINS AT BASELINE WERE 8 AND AT 2 AND 6 HOURS THERE WAS NO CHANGE FROM BASE
Patient problems: Angina; Chest Pain; Dizziness; Dyspnea; Heart Block; Restenosis
MAUDE report 25890213 ↗InjuryJul 6, 2026Entrapment of Device; Material Deformation
IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE NC EUPHORA RX CORONARY BALLOON, DEFLATION DIFFICULTIES WERE ENCOUNTERED. THREE WEEKS PRIOR TO THE PROCEDURE THE PATIENT DEVELOPED NEW ON-SET PALPITATIONS/ANGINA AND WAS PRESCRIBED MEDICATION. THE PALPITATIONS PERSISTED AND APPROXIMATELY 6 DAYS PRIOR TO THE PROCEDURE THE PATIENT SUFFERED A SEVERE EPISODE WITH A HEART RATE OF 138 BPM AND BLOOD PRESSURE OF 118/80 MMHG, THIS EPISODE WAS TREATED WITH MEDICATION AND SYMPTOMS WERE REDUCED. THREE DAYS PRIOR TO THE PROCEDURE, THE PATIENT UNDERWENT A CARDIA CT DUE TO CHEST PAIN AND PALPITATIONS. THE CARDIAC CT WAS ABNORMAL AND REVEALED SEVERE CORONARY ARTERY DISEASE (CAD). A LEFT HEART CATHETERIZATION PROCEDURE WAS PLANNED AND DURING THE ELECTIVE OUTPATIENT PROCEDURE, THE PATIENT WAS NOTED TO HAVE HEAVY AND SCATTERED CALCIFICATION, EXHIBITING 80% STENOSIS IN THE PROXIMAL AND MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH AN IFR MEASUREMENT OF 0.59, CONSISTENT WITH SIGNIFICANT AND OBSTRUCTIVE CORONARY ARTERY DISEASE. THE LEFT CORONARY ARTERY WAS ENGAGED USING A 6F LAUNCHER GUIDE CATHETER. THE LESION WAS PREDILATED WITH A NON-MEDTRONIC NC 3.0 MM BALLOON AND IVUS WAS PERFORMED. A DECISION WA
Patient problems: Cardiac Arrest; Heart Block; Obstruction/Occlusion; Tachycardia; Ventricular Fibrillation
MAUDE report 25716137 ↗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 ↗InjuryJun 5, 2026Device Dislodged or Dislocated; Material Deformation; Positioning Problem
DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT WHEN THE STENT WAS UNABLE TO CROSS A CALCIFIED, TORTUOUS LESION. UPON REMOVAL OF THE DELIVERY SYSTEM, THE STENT EMBOLISED OFF THE DELIVERY CATHETER AND TRAVELLED DOWN TO THE LEFT SUPERFICIAL FEMORAL ARTERY/PROFUNDA. THE DEVICE WAS SUCCESSFULLY REMOVED WITH A SNARE FROM A RIGHT FEMORAL APPROACH. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.
Patient problems: Foreign Body Embolism
MAUDE report 25408949 ↗MalfunctionMay 28, 2026Device Dislodged or Dislocated
DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT WHEN STENT DISLODGMENT OCCURRED DURING REMOVAL OF THE SHEATH. WHEN THE SHEATH WAS PULLED OFF THE BALLOON MOUNTED STENT, THE STENT REMAINED INSIDE THE SHEATH. IT WAS LATER REPORTED THAT IT WAS UNKNOWN WHETHER THE STENT BECAME DISLODGED DURING THE PREPARATION PROCESS. HOWEVER, AFTER THE BALLOON HAD BEEN INTRODUCED INTO THE PATIENT¿S BODY, IT WAS NOTED THAT THE STENT WAS NOT ON THE BALLOON. THE STENT WAS SUBSEQUENTLY FOUND INSIDE THE PROTECTIVE SLEEVE, WHICH HAD BEEN DISCARDED AND WAS LATER RECOVERED FROM THE TRASH. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE LESION INTENDED TO BE TREATED WAS A MODERATELY TORTUOUS LESION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25325393 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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