Orsiro Mission 2.5/35/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07640130456242), received between Feb 6, 2024 and Apr 28, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (6 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

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (99 % STENOSIS DEGREE) IN A SEVERELY TORTUOUS SEGMENT OF THE DISTAL RCA. A PRE-DILATION OF THE LESION WAS PER-FORMED. THE AFFECTED DEVICE WAS INTRODUCED INTO THE PATIENT'S BODY BUT COULD NOT CROSS THE LESION "DUE TO THE SEVERE TORTUOSITY OF THE VESSEL".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25013114 ↗
• MalfunctionFeb 13, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION IN A MODERATELY TORTUOUS SEGMENT OF THE PROXIMAL LCX. A PRE-DILATION OF THE LESION WAS PERFORMED. THE AFFECTED DEVICE WAS INTRODUCED INTO THE PATIENT'S BODY BUT COULD NOT CROSS THE LESION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24332224 ↗
• MalfunctionJan 7, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION WITH 60% STENOSIS DEGREE. IT IS UNKNOWN IF A PRE-DILATION OF THE LESION WAS PERFORMED. THE AFFECTED DEVICE WAS INTRODUCED INTO THE PATIENT'S BODY BUT COULD NOT CROSS THE LESION. THE COMPLAINT DEVICE WAS DISCARDED AT THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23988606 ↗
• MalfunctionDec 10, 2025Failure to Advance; Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION IN A SEVERELY TORTUOUS PART OF THE MID LAD. DESPITE PRE-DILATATION AND SEVERAL ATTEMPTS, THE DEVICE COULD NOT PASS THE LESION. ADDITIONAL BALLOON DILATATION WAS PERFORMED AND ANOTHER ORSIRO MISSION WAS INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23766960 ↗
• MalfunctionDec 3, 2025Failure to Advance; Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION IN A MODERATELY TORTUOUS PART OF THE MID RCA. THE DEVICE COULD NOT CROSS THE LESION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23703544 ↗
• MalfunctionJul 2, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE ORSIRO MISSION STENT WAS UNABLE TO CROSS THE SEVERELY CALCIFIED LESION IN THE LAD. WHEN THE DEVICE WAS REMOVED, IT WAS DISCOVERED THAT THE STENT WAS NO LONGER ON THE DELIVERY SYSTEM. THE STENT WAS FOUND AND LEFT IN THE LEFT ILIAC ARTERY. NO FURTHER TREATMENT WAS CONDUCTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22381661 ↗
• MalfunctionMay 29, 2024Material Deformation; Material Deformation

  AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. DURING UNPACKING, THE STENT LOOKED WARPED COMING OUT OF THE HOOP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19415268 ↗
• MalfunctionFeb 6, 2024Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION IN THE SEVERELY TORTUOUS DISTAL LCX. DESPITE PRE DILATATION, THE LESION COULD NOT BE CROSSED WITH THE DEVICE. THE LESION WAS RE DILATED WITH A LARGER NC BALLOON. UPON INSPECTION AND BEFORE RE-INSERTING THE STENT, THE PROXIMAL END OF THE STENT WAS OBSERVED TO BE DAMAGED. THERE WAS NO RESISTANCE IN REMOVING THE STENT INITIALLY FROM THE BODY. IT IS NOT CERTAIN WHAT CAUSED THE DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18649608 ↗