Orsiro Mission 4/22/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07640130456105), received between Dec 23, 2025 and Feb 4, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (80 % STENOSIS DEGREE) IN A MODERATELY TORTUOUS SEGMENT OF THE DISTAL RCA. A PRE-DILATION OF THE LESION WAS PERFORMED VIA SHOCKWAVE BALLOON. 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 24256793 ↗
• MalfunctionJan 12, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (90 % STENOSIS DEGREE) IN A SEVERELY TORTUOUS SEGMENT OF THE DISTAL RCA-PLA. A PRE-DILATION OF THE LESION WAS PERFORMED, AND THE AFFECTED DEVICE WAS INTRODUCED INTO THE PATIENT'S BODY BUT COULD NOT CROSS THE LESION. IT WAS POSSIBLE TO CROSS THE LESION USING A 2.25/9 ORSIRO MISSION, FOLLOWED BY ANOTHER 2.25/9 ORSIRO MISSION WITHOUT ISSUE AND GOOD RESULT. THE COMPLAINT DEVICE WAS DISCARDED AT THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24035383 ↗
• MalfunctionDec 23, 2025Failure to Advance; Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (90 % STENOSIS DEGREE) IN A SEVERELY TORTUOUS SEGMENT OF THE MEDIAL TO DISTAL RCA. A PRE-DILATION OF THE LESION WAS PERFORMED WITH. 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 3.5/22 ORSIRO MISSION. THE COMPLAINT DEVICE WAS DISCARDED AT THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23874594 ↗