Onyx Frontier™ ONYXNG45018UXRecalls & reported problems
Medtronic, Inc. · STENT ONYXNG45018UX ONYX 4.50X18RX · Class 3 · Implant
All models of Onyx Frontier (71)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000511746), received between Aug 15, 2025 and Aug 15, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Activation, Positioning or Separation Problem1
- Detachment of Device or Device Component1
- Device Damaged by Another Device1
- Entrapment of Device1
- Material Deformation1
Patient problems
- Cardiovascular Dysfunction/Insufficiency1
- Device Embedded In Tissue or Plaque1
- Ischemia1
- Myocardial Infarction1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 15, 2025Entrapment of Device; Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Device Damaged by Another Device; Material Deformation; Entrapment of Device; Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Device Damaged by Another Device; Material Deformation
ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT WAS IMPLANTED IN A PATIENT. APPROXIMATELY 3 MONTHS LATER THE PATIENT UNDERWENT A BALLOON ANGIOPLASTY PROCEDURE OF THE LEFT MAIN CORONARY ARTERY IN TO THE LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH A 5X15MM NON COMPLIANT BALLOON. THE BALLOON BECAME STUCK WITHIN THE STENT AND IT WAS NOT POSSIBLE TO MOVE THE BALLOON OR WIRE INDEPENDENTLY. ALL WIRES AND CATHETER WAS PULLED OUT AS ONE UNIT. UPON REMOVING THE BALLOON CATHETER, IT APPEARED THAT A SEGMENT OF THE ONYX FRONTIER STENT WAS STUCK TO THE BALLOON AND WAS RETRIEVED ALONG WITH THE BALLOON. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED A RESULT OF THIS EVENT.
Patient problems: Cardiovascular Dysfunction/Insufficiency; Device Embedded In Tissue or Plaque; Ischemia; Myocardial Infarction; No Clinical Signs, Symptoms or Conditions
MAUDE report 22813548 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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