Resolute Onyx™ RONYX30034WRecalls & reported problems
Medtronic, Inc. · STENT RONYX30034W RESOLUTE ONYX 3.00X34 · Class 3 · Implant
All models of Resolute Onyx (101)
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 00643169602557), received between Sep 23, 2019 and Sep 23, 2019 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Myocardial Infarction1
- Occlusion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DURING INDEX PROCEDURE, TWO RESOLUTE ONYX DRUG-ELUTING STENTS WERE IMPLANTED IN THE RCA. TWO DAYS LATER A STAGED PROCEDURE WAS CARRIED OUT TO TREAT THE LAD WITH THE IMPLANTATION OF THREE RESOLUTE ONYX DRUG-ELUTING STENTS. POST STAGED PROCEDURE, A PLAQUE SHIFT OCCURRED IN 2ND DIAGONAL WITH TIMI FLOW 1-2 CAUSING ST ELEVATION IN LATERAL LEADS ON TELEMETRY. INVESTIGATOR ASSESSED EVENT IS PROBABLY RELATED TO DEVICE AND NOT RELATED TO ANTI-PLATELET MEDICATION. CEC ADJUDICATED EVENT AS A NON-Q WAVE MI OF THE TARGET VESSEL, 3RD UDMI PERI-PCI AND SLOW FLOW IN DIAGONAL.
Patient problems: Myocardial Infarction; Occlusion
MAUDE report 9103968 ↗
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- SYNERGY™ H7493926020300Boston Scientific Corporation · Coronary drug-eluting stent9 deaths90 reports
- SYNERGY™ H7493926016250Boston Scientific Corporation · Coronary drug-eluting stent6 deaths82 reports
- XIENCE Sierra™ 1550350-33Abbott Vascular Inc. · Coronary drug-eluting stent1 recall32 reports
- Resolute Onyx™ RONYX30022UXMedtronic, Inc. · Coronary drug-eluting stent6 deaths76 reports
- SYNERGY™ H7493926024300Boston Scientific Corporation · Coronary drug-eluting stent3 deaths75 reports
- Resolute Onyx™ RONYX30015UXMedtronic, Inc. · Coronary drug-eluting stent3 deaths73 reports
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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