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Orsiro 3.0/35/140Recalls & reported problems

Biotronik AG · Class 3 · Implant

All models of Orsiro (49)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
5
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07640130439382), received between Aug 21, 2019 and Nov 10, 2021 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (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 16, 2026.

Most reported problems

Device problems

  • Failure to Advance1
  • Inflation Problem1
  • Material Deformation1
  • Patient Device Interaction Problem1
  • Use of Device Problem1

Patient problems

  • No Consequences Or Impact To Patient2
  • Cardiac Arrest1
  • No Clinical Signs, Symptoms or Conditions1
  • Thrombosis/Thrombus1
  • Vascular Dissection1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • InjuryNov 10, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

    7 DAYS AFTER THE ORSIRO DRUG-ELUTING STENT IMPLANTATION IN THE PROX. LAD, THE PATIENT RETURNED TO THE HOSPITAL WITH A CARDIAC ARREST. A 100 PERCENT SUBACUTE STENT THROMBOSIS WAS DETECTED AND TREATED WITH ASPIRATION THROMBECTOMY AND A BALLOON DILATION INSIDE THE STENT.

    Patient problems: Cardiac Arrest; Thrombosis/Thrombus

    MAUDE report 12787400 ↗
  • MalfunctionMar 29, 2021Inflation Problem; Inflation Problem

    AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. IT WAS NOT POSSIBLE TO DEPLOY THE STENT TO TARGET LESION. THE BALLOON WAS INFLATED BUT THE STENT DID NOT DEPLOY. THE INFLATION PRESSURE IS UNKNOWN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11581910 ↗
  • InjuryDec 12, 2020Use of Device Problem; Use of Device Problem

    (B)(6) STUDY: THE ORSIRO DRUG ELUTING STENT SYSTEM WAS CHOSEN FOR THE TREATMENT. AFTER DEPLOYMENT A DISSECTION OCCURRED AND THEN IT WAS DECIDED TO USE ANOTHER ORSIRO TO COVER THE DISSECTION SUCCESSFULLY.

    Patient problems: Vascular Dissection

    MAUDE report 10996502 ↗
  • MalfunctionMar 31, 2020Material Deformation; Material Deformation

    AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT OF A SVG. THE DEVICE COULD NOT BE ADVANCED THROUGH A 6F GUIDELINER AND WAS REMOVED. AFTER REMOVAL IT WAS DETECTED THAT THE STENT WAS DEFORMED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9908661 ↗
  • MalfunctionAug 21, 2019Failure to Advance; Failure to Advance

    THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR USE. AFTER PRE-DILATATION THE CALCIFIED AND TORTUOUS TARGET LESION COULD NOT BE CROSSED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8915697 ↗

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Sources and updates

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