Orsiro Mission 2.25/30/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07640130456174), received between Nov 2, 2021 and May 5, 2026 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2026Failure to Advance

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25079822 ↗
• MalfunctionMar 17, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (95 % STENOSIS DEGREE) IN A MODERATELY TORTUOUS SEGMENT OF THE DISTAL 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 24616623 ↗
• MalfunctionJan 27, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (80 % STENOSIS DEGREE) IN A SEVERELY 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. THE PHYSICIAN WAS ABLE TO CROSS THE LESION USING A 2.5/18 ORSIRO MISSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24188024 ↗
• MalfunctionFeb 20, 2025Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE ORSIRO MISSION STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION WITHOUT PRE-DILATATION. THE DEVICE WAS PULLED BACK OUT OF PATIENT, AND IT WAS DETECTED THAT ONE STRUT WAS BENT. SUBSEQUENTLY, PRE-DILATATION WAS PERFORMED, AND A 2ND STENT OF SAME SIZE WAS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21421993 ↗
• MalfunctionMar 23, 2022Material Deformation; Material Deformation

  AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. A STENT DEFORMATION WAS DETECTED RIGHT OUT OF THE PACKAGING. A STRUT WAS STICKING OUT AT MID STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13871161 ↗
• MalfunctionNov 2, 2021Fracture; Fracture

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A PRE-DILATED LESION. WHEN INTRODUCING THE DEVICE INTO THE BODY, THE BACK END OF THE SHAFT BENT. RESISTANCE WAS FELT WHEN THE DEVICE WAS ADVANCED DEEPER INTO THE VESSEL. BY PUSHING HARDER, THE KINK GOT WORSE. WHILE REMOVING THE STENT SYSTEM FROM THE GUIDE, THE BACK END OF THE SHAFT BROKE APART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12741002 ↗