Orsiro Mission 3/9/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07640130455849), received between Dec 3, 2025 and Apr 24, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (8 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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION IN AN 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 24977858 ↗
• MalfunctionApr 10, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION IN AN 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 24843629 ↗
• MalfunctionApr 10, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (90 % STENOSIS DEGREE) IN A MILDLY 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 "DUE TO SIGNIFICANT CALCIUM IN THE RCA".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24843265 ↗
• MalfunctionApr 10, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION IN A SEGMENT OF THE PROXIMAL TO MEDIAL BIFURCATION TO THE D1. 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 24842631 ↗
• MalfunctionMar 24, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION IN A MODERATELY TORTUOUS SEGMENT OF THE PROXIMAL LCX. A PRE-DILATION OF THE LESION WAS NOT 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 24672232 ↗
• MalfunctionMar 18, 2026Failure to Unfold or Unwrap

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION WITH (80% STENOSIS DEGREE) IN A MILDLY TORTUOUS SEGMENT OF THE PROXIMAL LAD. AFTER THE DEVICE HAD BEEN ADVANCED TO THE PRE-DILATED TARGET LESION, THE BALLOON WAS INFLATED TO 10 ATM IN VITRO, BUT THE STENT DID NOT DEPLOY. INSTEAD, IT "DOG BONED". THE STENT WAS REMOVED FROM THE PATIENT AND INFLATED TO 18 ATM ON THE BENCH. THE STENT REMAINS EMBEDDED ON THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24631161 ↗
• MalfunctionFeb 27, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION IN AN UNKNOWN TARGET VESSEL (100% STENOSIS DEGREE). 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 24469198 ↗
• MalfunctionFeb 4, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION (80 % STENOSIS DEGREE) IN A MILDLY TORTUOUS SEGMENT OF A MEDIAL CORONARY 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. THE COMPLAINT DEVICE WAS NOT RETURNED FROM THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24256792 ↗
• MalfunctionDec 3, 2025Failure to Advance; Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION IN A SEVERELY TORTUOUS PART OF THE MID LAD. THE DEVICE COULD NOT CROSS THE LESION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23703932 ↗