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Onyx Frontier™ ONYXNG22534UXRecalls & reported problems

Medtronic, Inc. · STENT ONYXNG22534UX ONYX 2.25X34RX · Class 3 · Implant

All models of Onyx Frontier (71)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000511258), received between Mar 2, 2023 and Aug 1, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Damaged by Another Device” (2 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

Device problems

  • Device Damaged by Another Device2
  • Device Dislodged or Dislocated2
  • Detachment of Device or Device Component1

Patient problems

  • Insufficient Information2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 1, 2023Device Damaged by Another Device; Device Dislodged or Dislocated; Device Damaged by Another Device; Device Dislodged or Dislocated

    AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG-ELUTING STENT TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION WITH 80% STENOSIS IN THE MID CIRCUMFLEX (CX) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS NOT PRE-DILATED. THE DEVICE PASSED 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/AT THE LESION. IT WAS DETAILED THAT THE PATIENT HAD A STENT IMPLANTED TWO MONTHS EARLIER IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. DURING THE CURRENT PROCEDURE, THE ONYX FRONTIER STENT WAS ADVANCED TO TREAT A SECOND LESION IN THE CX. THE ONYX FRONTIER STENT BECAME ENTANGLED WITH THE EXPOSED STRUTS OF THE RECENTLY IMPLANTED STENT IN THE PROXIMAL LAD. A SNARE WAS USED TO REMOVE THE DISLODGED ONYX FRONTIER STENT. NO FURTHER PATIENT INJURY WAS REPORTED.

    Patient problems: Insufficient Information

    MAUDE report 17436221 ↗
  • InjuryMar 2, 2023Detachment of Device or Device Component; Device Damaged by Another Device; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Damaged by Another Device; Device Dislodged or Dislocated

    AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS LESION IN THE OSTIUM OF THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE DEVICE PASSED 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/AT THE LESION. THE STENT GOT STUCK IN THE LEFT MAIN (LM) STENT. WHEN IT WAS ATTEMPTED TO EXTRACT THE DISLODGED DEVICE, THE STENT BROKE. THE DETACHED PORTION WAS EXTRACTED SEPARATELY. EVERYTHING WAS REMOVED VIA A SNARE. NO FURTHER PATIENT INJURY WAS REPORTED.

    Patient problems: Insufficient Information

    MAUDE report 16468015 ↗

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Sources and updates

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