Orsiro Mission 2.25/26/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07640130456112), received between Dec 2, 2025 and Sep 16, 2026 — classified as 1 injury, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Failure to Advance

  The Orsiro Mission drug-eluting stent system was selected for treatment of a mildly calcified lesion in a moderate tortuous segment of the OM. After pre-dilatation, the device was introduced into the patient's body but could not pass the lesion. A shorter stent was used successfully to finish the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50782790 ↗
• InjuryMay 13, 2026Failure to Advance; Device Dislodged or Dislocated

  ORSIRO MISSION WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (100% STENOSIS DEGREE) IN A MODERATELY TORTUOUS PART OF A TOTALLY OCCUPIED RCA BY DIRECT STENTING. THREE ORSIRO MISSIONS STENTS WERE SUCCESSFULLY IMPLANTED FROM THE OSTIUM TO THE DISTAL RCA. THEREAFTER, THE AFFECTED ORSIRO MISSION WAS INTRODUCED BUT "WAS HELD UP GOING THROUGH THE PROXIMAL STENT". DURING DEVICE WITHDRAWAL, THE STENT DISLODGED FROM THE BALLOON, LEAVING THE STENT HALF IN PROXIMAL RCA AND IN THE GUIDING CATHETER. THE STENT WAS SUCCESSFULLY RETRIEVED WITH A SNARE. IN AN ADDITIONAL INTERVENTION TWO DAYS LATER, A STENT COULD BE SUCCESSFULLY IMPLANTED IN THE DISTAL RCA. THE PATIENT DID FINE AND WAS DISCHARGED HOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25159498 ↗
• MalfunctionDec 4, 2025Failure to Advance; Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (80% STENOSIS DEGREE) IN A MILDLY TORTUOUS PART OF THE MID LAD. THE DEVICE COULD NOT PASS THE LESION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23712910 ↗
• MalfunctionDec 2, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (70% STENOSIS DEGREE) IN A SEVERELY TORTUOUS PART OF THE LAD. THE LESION CONDITION LED TO SEVERAL CROSSING ISSUES WITH E.G. THE GUIDEWIRE, IVUS AND OTHER STENTS. ULTIMATELY THE ORSIRO MISSION DID CROSS. UPON PULLING THE STENT CATHETER BACK FOR EXACT PLACEMENT, THE STENT DISLODGED FROM THE BALLOON. AFTER PASSING A 2.25 BALLOON THOUGH THE UNDEPLOYED STENT, THE STENT WAS DEPLOYED WITHIN THE LESION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23692158 ↗