Orsiro Mission 3/18/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07640130456020), received between Mar 9, 2022 and Jun 5, 2026 — classified as 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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION (70 % STENOSIS DEGREE) 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 25405790 ↗
• MalfunctionMay 22, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (85 % STENOSIS DEGREE) IN A MODERATELY TORTUOUS SEGMENT OF THE PROXIMAL LAD. A PRE-DILATION WITH MULTIPLE BALLOONS 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 25255098 ↗
• MalfunctionJan 9, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY TO SEVERELY CALCIFIED LESION (70 % STENOSIS DEGREE) IN A MODERATELY TORTUOUS SEGMENT OF THE MEDIAL LAD. A PRE-DILATION OF THE LESION WAS PERFORMED. UNDER USE OF A GUIDE WIRE AND A 6F TERUMO INTRODUCER WITHOUT A GUIDING CATHETER THE AFFECTED DEVICE WAS INTRODUCED INTO THE PATIENT'S BODY BUT COULD NOT CROSS THE LESION. THE COMPLAINT DEVICE WAS NOT RETURNED FROM THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24017605 ↗
• MalfunctionMar 9, 2022Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. IT WAS ATTEMPTED TO PLACE THE ORSIRO MISSION IN THE DISTAL RCA, BUT THE STENT COULD NOT PASS THE LESION AND WAS REMOVED FOR ANOTHER PRE-DILATATION OF THE LESION. SECOND ATTEMPT WAS ALSO UNSUCCESSFUL AND ANOTHER DILATATION WAS CONDUCTED. ON THE THIRD ATTEMPT IT WAS NOTICED THAT THE STENT DISLODGED FROM THE BALLOON AND IT WAS NOT POSSIBLE TO RETRIEVE IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13710812 ↗