Orsiro Mission 2.5/30/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07640130456181), received between Nov 22, 2021 and May 22, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (5 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.

• MalfunctionMay 22, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (90 % STENOSIS DEGREE) IN A MODERATELY TORTUOUS SEGMENT OF THE DISTAL RCA. THE AFFECTED DEVICE WAS INTRODUCED INTO THE PATIENT'S BODY BUT COULD NOT CROSS THE LESION "DUE TO THE CALCIFICATION".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25252699 ↗
• MalfunctionApr 10, 2026Device Dislodged or Dislocated

  THE ORSIRO MISSION US STENT SYSTEM WAS DELIVERED TO THE TARGET LESION WITHIN THE LAD BUT AFTER INFLATION THE VESSEL APPEARED THE SAME AND IT WAS NOTICED THATE THERE WAS NO STENT LOADED ON THE BALLOON. ANOTHER STENT WAS THEN SUCCESSFULLY DEPLOYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24842542 ↗
• MalfunctionMar 24, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION IN A SEGMENT OF UNSPECIFIED VESSEL. 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 24679600 ↗
• MalfunctionMar 17, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A IN A MODERATELY TO SEVERELY TORTUOUS SEGMENT FROM THE DISTAL RCA, IN A MEDIAL PLA. A PRE-DILATION OF THE LESION WAS PERFORMED, BUT "AS THE VESSEL WAS VERY TORTUOUS, THE DOCTOR HAD DIFFICULTY TO CROSS WITH BALLOONS". A SHOCKWAVE BALLOON FAILED TO CROSS. THE AFFECTED COMPLAINT DEVICE WAS INTRODUCED INTO THE PATIENT'S BODY BUT COULD NOT CROSS THE LESION "DUE TO THE SEVERE TORTUOSITY". THE PHYSICIAN LEFT THE LESION USING POBA ONLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24616624 ↗
• MalfunctionMar 17, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION IN A SEVERELY TORTUOUS SEGMENT OF THE DISTAL RCA. 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 24615211 ↗
• MalfunctionMar 18, 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 WITH 85 PERCENT STENOSIS DEGREE. DESPITE PRE-DILATATION, THE LESION COULD NOT BE CROSSED WITH THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18923143 ↗
• MalfunctionOct 25, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION IN THE RCA. THE DEVICE WAS ADVANCED TO THE MID PART OF THE RCA AND INFLATED TO NOMINAL PRESSURE. IN THE POST-ANGIO THE LESION LOOKED TO BE THE SAME AND THE STENT WAS NOT SEEN. FLURO WAS THEN USED TO TRACE THE CATHETER, BUT THE STENT WAS NOT VISIBLE. THE BACK OF THE TABLE WAS CHECKED, AND IT WAS NOTICED THAT THE STENT WAS STILL ON THE STYLET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18004103 ↗
• MalfunctionNov 22, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF THE LAD. THE ARTERY WAS HEAVILY CALCIFIED, SHOCKWAVE WAS USED AS WELL AS PREDILATATION WAS PERFORMED. THE STENT FELL OFF THE BALLOON IN THE LEFT MAIN. THE STENT WAS RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12853362 ↗