Orsiro Mission 2.25/22/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07640130456051), received between Apr 7, 2022 and Apr 14, 2026 — classified as 1 injury, 5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION IN A SEVERELY TORTUOUS SEGMENT OF THE DISTAL RCA-PLA. 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 24870949 ↗
• MalfunctionMar 11, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION IN A SEGMENT OF THE DISTAL RPDA. 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 24573803 ↗
• MalfunctionMar 10, 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 MEDIAL 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24558632 ↗
• InjuryJul 23, 2025Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION (70 % STENOSIS DEGREE) IN A MILDLY TORTUOUS SEGMENT OF THE PROXIMAL D1. AN UNKNOWN STENT WAS IMPLANTED PREVIOUSLY IN THE LAD, BUT UNCLEAR IF IT WAS IN THE SAME INTERVENTION. AFTER THE LAD STENT WAS FENESTRATED AND THE TARGET LESION WAS PRE-DILATED, THE COMPLAINT DEVICE WAS INTRODUCED INTO THE PATIENT BUT FAILED TO FULLY CROSS THE TARGET LESION. DURING THE ATTEMPT TO REMOVE THE COMPLAINT DEVICE, THE STENT DISLODGED INTO THE PROXIMAL LAD. A SNARING ATTEMPT HAD TO BE INTERRUPTED AS THE PATIENT DEVELOPED A STEMI AND THE PHYSICIAN DECIDED TO CRUSH THE DISLODGED STENT TO THE VESSEL WALL IN THE PROXIMAL LAD. AFTERWARDS, ANOTHER STENT SYSTEM WAS SUCCESSFULLY IMPLANTED OVER THE LENGTH OF THE CRUSHED STENT. ANOTHER MANUFACTURERS STENT WAS IMPLANTED INTO THE PROXIMAL D1 SEGMENT INSTEAD. THE COMPLAINT DEVICE WAS DISCARDED AT THE HOSPITAL.

  Patient problems: Myocardial Infarction

  MAUDE report 22574256 ↗
• MalfunctionApr 11, 2022Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION IN THE DISTAL LAD. THE PRE-DILATED LESION COULD NOT BE CROSSED WITH THE DEVICE. THE DEVICE WAS REMOVED, AND IT WAS NOTICED THAT THE STENT HAS BEEN DISLODGED. THE STENT WAS FOUND INSIDE THE LESION AND IT WAS POSSIBLE TO GET A SMALL BALLOON INTO THE STENT TO DEPLOY IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14074385 ↗
• MalfunctionApr 7, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN THE MILDLY TORTUOUS RIGHT POSTEROLATERAL ARTERY. WHILE ATTEMPTING TO PLACE THE STENT BY DIRECT STENTING THROUGH THE 6F GUIDELINER, THE STENT GOT CAUGHT ON THE PROXIMAL EDGE OF THE GUIDELINER AND CAME OFF THE BALLOON. STENT WAS RETRIEVED AND REMOVED FROM THE BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14047506 ↗