Orsiro Mission 3.0/35/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07640130456266), received between Aug 9, 2023 and Jul 22, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (10 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2026Failure to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25904079 ↗
• MalfunctionJun 5, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION IN A SEGMENT OF THE MEDIAL LCX. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25405789 ↗
• MalfunctionApr 29, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION IN THE LAD. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25024846 ↗
• MalfunctionMar 17, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION IN A MODERATELY TORTUOUS SEGMENT OF THE MEDIAL LAD. 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 24616622 ↗
• MalfunctionMar 11, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (80 % STENOSIS DEGREE) IN A MODERATELY TORTUOUS SEGMENT OF THE MEDIAL 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 "BECAUSE OF VESSEL CALCIFICATION AND TORTUOSITY".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24566320 ↗
• MalfunctionMar 6, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (95 % STENOSIS DEGREE) IN A MODERATELY TORTUOUS PART OF THE MID LCX. THE LESION WAS PRE-DILATED, AND THE AFFECTED DEVICE WAS INTRODUCED INTO THE PATIENT'S BODY BUT COULD NOT CROSS THE LESION. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24529524 ↗
• MalfunctionFeb 20, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION (60 % STENOSIS DEGREE) IN A SEGMENT OF A MEDIAL CORONARY VESSEL. IT IS UNCLEAR 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24399554 ↗
• MalfunctionFeb 13, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION IN A TORTUOUS SEGMENT OF THE MEDIAL LAD. 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. IT WAS POSSIBLE TO CROSS THE LESION USING A SHORTER STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24332300 ↗
• MalfunctionOct 9, 2025Failure to Advance; Failure to Advance

  TWO ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION. THE DEVICES OF THE SAME LOT COULD NOT BE DELIVERED THROUGH THE LESION. THIS 2 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23254439 ↗
• MalfunctionOct 9, 2025Failure to Advance; Failure to Advance

  TWO ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION. THE DEVICES OF THE SAME LOT COULD NOT BE DELIVERED THROUGH THE LESION. THIS 1OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23254170 ↗
• MalfunctionAug 9, 2023Material Deformation; Material Deformation

  AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF THE PROXIMAL RCA. AFTER UNPACKING PRIOR TO USE, IT WAS DETECTED THAT THE FIRST ORSIRO MISSION HAD STRUTS STICKING OUT. A SECOND ORSIRO MISSION WAS DEPLOYED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17490349 ↗