Resolute Onyx™ RONYX27522WRecalls & reported problems
Medtronic, Inc. · STENT RONYX27522W RESOLUTE ONYX 2.75X22 · 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 00643169602434), received between Sep 26, 2018 and Sep 26, 2018 — 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
- Reaction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT PRESENTED TO HOSPITAL WITH A HEART ATTACK AND HAD AN INDEX PROCEDURE ON (B)(6) 2018 WHERE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT WAS IMPLANTED (2.75X22MM). TWO ADDITIONAL RESOLUTE ONYX RX CORONARY DRUG ELUTING STENTS WERE IMPLANTED TWO DAYS LATER, DURING A STAGED PROCEDURE, BECAUSE MORE DISEASE WAS SEEN. THE HOSPITAL DID NOT FILL OUT THE STENT ID CARD. PATIENT STATES HAVING ISSUES SINCE STENT IMPLANTATION. PATIENT STATES HAVING SWELLING ON INSIDE AND OUTSIDE OF MOUTH AND DOWN TO CHEST AND NECK. STATES SKIN HURTS AND IS TENDER AND SWOLLEN. THE SYMPTOMS WERE EXPERIENCED WHILE THE PATIENT WAS IN THE HOSPITAL BUT THE PATIENT WAS ALSO ON VERY HIGH DOSE OF PREDNISONE FOR CHRON'S DISEASE AND IS STILL ON THIS AND SUFFERS FROM AN AUTOIMMUNE DISORDER. PATIENT STATES BEING ALLERGIC TO SULPHA AND NICKEL. PATIENT ALSO STATES THEY ARE NOT TAKING THEIR MEDICATION. PATIENT HAS BEEN TAKEN OFF TWO MEDICATIONS AND THE DOSAGES REDUCED ON TWO. THE PATIENT IS DUE TO SEE AN ALLERGIST ON (B)(6) 2018. PATIENT IS FEELING A LITTLE BIT BETTER AND THE SYMPTOMS COME AND GO. CLINICAL ASSESSMENT: POSSIBILITY THAT SYMPTOMS COULD BE DUE TO PATIENT NOT TAKING MEDICATION.
Patient problems: Reaction
MAUDE report 7909897 ↗
Other Coronary drug-eluting stent devices
- SYNERGY™ H7493926038300Boston Scientific Corporation · Coronary drug-eluting stent8 deaths124 reports
- SYNERGY™ H7493926016300Boston Scientific Corporation · Coronary drug-eluting stent7 deaths106 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page