Orsiro Mission 2.75/18/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07640130456013), received between Jan 12, 2022 and Mar 6, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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.

• MalfunctionMar 6, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION IN AN UNKNOWN TARGET VESSEL. 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 24529522 ↗
• MalfunctionMar 5, 2025Fluid/Blood Leak; Material Rupture; Fluid/Blood Leak; Material Rupture

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A PREDILATED LESION IN THE DISTAL RCA. THE STENT BALLOON RUPTURED PRIOR TO DEPLOYING THE STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21527477 ↗
• MalfunctionFeb 15, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A DISTAL LAD LESION. THE STENT WAS DELIVERED BUT NEEDED TO CHANGE POSITION, SINCE IT MOVED. AFTER REPOSITIONING IT WAS NOTICED THAT THE STENT WAS DISLODGED. THE STENT DELIVERY WAS PULLED BACK, AND IT WAS CONFIRMED THAT THE STENT HAD DISLODGED. ANOTHER STENT WAS DEPLOYED TO CRUSH THE DISLODGED STENT AGAINST THE VESSEL WALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18712744 ↗
• InjuryJan 12, 2022Material Deformation; Migration; Material Deformation; Migration

  AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION WITH 99 PERCENT STENOSIS DEGREE IN THE CX. AFTER POST-DILATATION OF THE ORSIRO MISSION STENT WITH AN NC BALLOON AND FURTHER PREPARATION OF ANOTHER DISTAL LESION, THE BALLOON GOT STUCK AT THE DISTAL END OF THE IMPLANTED STENT. DURING WITHDRAWAL OF THE BALLOON, THE PREVIOUSLY IMPLANTED STENT BECAME DEFORMED, MIGRATED AND WAS FINALLY ADAPTED TO THE VESSEL WALL. ADDITIONALLY, THERE WAS A NON-FLOW-LIMITING DISSECTION WHICH WAS TREATED WITH A DES. FINALLY, THE PATIENT WAS STABLE AND WAS DISCHARGED HOME.

  Patient problems: Vascular Dissection

  MAUDE report 13236397 ↗