Orsiro Mission 2.5/13/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07640130455887), received between May 24, 2022 and May 22, 2026 — classified as 7 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 7 most recent of 7 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 SEVERELY CALCIFIED LESION (70 % STENOSIS DEGREE) IN A SEGMENT OF A DISTAL VESSEL. 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 25252700 ↗
• MalfunctionApr 28, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (85 % STENOSIS DEGREE) IN A MILDLY 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 25013450 ↗
• MalfunctionApr 22, 2026Inflation Problem

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. IT WAS NOT POSSIBLE TO INFLATE THE DELIVERY BALLOON OF THE ORSIRO MISSION STENT SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24949816 ↗
• 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 SEGMENT OF THE DISTAL LCX. A PRE-DILATION OF THE LESION WAS PERFORMED USING A SHOCKWAVE IVL BALLOON. UNDER USE OF A TELESCOPE GUIDING EXTENSION CATHETER 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 24615217 ↗
• MalfunctionFeb 27, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION IN THE LAD. 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 24469202 ↗
• MalfunctionNov 17, 2025Failure to Advance; Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (99 % STENOSIS DEGREE) IN A MODERATELY TORTUOUS SEGMENT OF A MEDIAL TO DISTAL LCX. AFTER 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 23567214 ↗
• MalfunctionMay 24, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO MISION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF THE MID CX. THE STENT CAME OFF THE STENT BALLOON PRIOR TO THE LESION. THE STENT WAS REMOVED SUCCESSFULLY BY USING A SNARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14488065 ↗