Orsiro Mission 3/26/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07640130456143), received between Feb 7, 2023 and Jun 1, 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.

• MalfunctionJun 1, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (95% STENOSIS DEGREE) IN A SEVERELY TORTUOUS SEGMENT OF PROXIMAL LAD. THE DEVICE WAS NOT ABLE TO CROSS AN EXISTING STENT. ANOTHER STENT WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25345661 ↗
• MalfunctionMay 26, 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 OSTIAL LAD. 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 25273767 ↗
• MalfunctionMar 11, 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 MEDIAL LAD. IT IS UNCLEAR 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 24566321 ↗
• MalfunctionDec 4, 2025Failure to Advance; Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION IN A MODERATELY TORTUOUS OM. DEVICE DID NOT CROSS, NO OTHER STENTS WERE TRIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23713239 ↗
• MalfunctionDec 27, 2023Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. AFTER THE LESION COULD NOT BE CROSSED, THE DEVICE WAS WITHDRAWN. IT WAS DETECTED THAT THE STENT DISLODGED. THE STENT WAS SUCCESSFULLY RETRIEVED WITH A SNARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18406836 ↗
• MalfunctionApr 20, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (99 PERCENT STENOSIS DEGREE) IN THE MILDLY TORTUOUS DISTAL CX. WHILE TRYING TO DELIVER THE DEVICE DOWN THE CX, THE PHYSICIAN WAS UNABLE TO DELIVER IT. HE THEN TRIED A 6F GUIDELINER, AND THE MISSION STENT WAS BEING HUNG UP ON A PROXIMAL LAD STENT. WHEN HE PULLED BACK THE MISSION STENT, IT CAME OFF THE BALLOON AND WAS STUCK IN THE LM. HE TRIED MULTIPLE TIMES TO RETRIEVE THE STENT AND WAS FINALLY ABLE TO WITH A SNARE. HE DID KISSING BALLOONS IN THE CX AND LAD AND WAS ABLE TO DELIVER TWO MISSION INTO THE CX. PATIENT WAS DOING OK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16779268 ↗
• MalfunctionFeb 7, 2023Material Deformation; Material Deformation

  AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. AFTER THE DEVICE WAS TAKEN OUT OF TRANSPORTATION RING, IT WAS NOTICED THAT THE STENT LOOKED FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16312868 ↗