Orsiro 3.5/26/140Recalls & reported problems
Biotronik AG · Class 3 · Implant
All models of Orsiro (49)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07640130439184), received between Jun 28, 2019 and Nov 10, 2020 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Failure to Advance” (4 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
- Failure to Advance4
- Patient Device Interaction Problem1
Patient problems
- No Consequences Or Impact To Patient4
- Thrombosis/Thrombus1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryNov 10, 2020Patient Device Interaction Problem; Patient Device Interaction Problem
AN ORSIRO US DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. THE PROXIMAL LAD WAS UNEVENTFUL AND SUCCESSFULLY STENTED WITH THE ORSIRO US STENT. THERE WAS AN ABRUPT CLOSURE OF A 2MM DIAGONAL VESSEL WITH STENT IMPLANTATION, WHICH RESULTED IN SOME CHEST DISCOMFORT AND MINIMAL ST ELEVATION IN THE LATERAL LEADS. THIS WAS EXPECTED TO BE TEMPORARY WITH EXPECTED RETURN OF FLOW. AFTER PROCEDURE PATIENT EXPERIENCED CHEST PAIN. A STENT THROMBOSIS WAS DETECTED APPROX 2 HOURS AFTER IMPLANTATION.
Patient problems: Thrombosis/Thrombus
MAUDE report 10818103 ↗MalfunctionAug 15, 2019Failure to Advance; Failure to Advance
THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR USE. AFTER PRE-DILATATION THE CALCIFIED TARGET LESION IN THE PROXIMAL RCA COULD NOT BE CROSSED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8896340 ↗MalfunctionJul 18, 2019Failure to Advance; Failure to Advance
THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR USE. AFTER PRE-DILATATION THE ORSIRO COULD NOT PASS THE SEVERELY CALCIFIED LESION IN THE MID LAD.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8803047 ↗MalfunctionJul 1, 2019Failure to Advance; Failure to Advance
AN ORSIO DRUG-ELUTING STENT SYSTEM WAS CHOSEN TO TREAT A SEVERE CALCIFIED LESION (100% STENOSIS DEGREE) IN A TORTUOUS RCA. THE DEVICE COULD NOT PASS THE UNDILATED LESION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8750625 ↗MalfunctionJun 28, 2019Failure to Advance; Failure to Advance
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN TO TREAT A SEVERELY CALCIFIED LESION IN AN LAD BUT THE TARGET LESION COULD NOT BE CROSSED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8746010 ↗
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