Orsiro Mission 2.75/30/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07640130456198), received between Apr 13, 2022 and Apr 10, 2026 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 10, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT A LESION IN A SEGMENT OF THE PROXIMAL TO MEDIAL LCX. IT IS UNKNOWN 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 24842539 ↗
• MalfunctionMar 17, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION IN A SEGMENT OF THE MEDIAL LAD. IT IS UNKNOWN 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 24615439 ↗
• MalfunctionDec 9, 2025Failure to Advance; Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION WITH 80% STENOSIS DEGREE IN A MODERATELY TORTUOUS PART OF THE MID LAD. THE LESION COULD NOT BE CROSSED WITH THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23754113 ↗
• MalfunctionMar 14, 2024Use of Device Problem; Use of Device Problem

  AN ORSIRO MISSION DRUG-ELUTING STENT, WHICH WAS EXPIRED ON 11-FEB-2024, WAS SUCCESSFULLY IMPLANTED ON (B)(6) 2024 IN THE LAD. IT WAS NOTED THAT THE STAFF ADDED A RED STICKER, INDICATING THE AFFECTED DEVICE WAS EXPIRING SOON, AND IT HAD A 2/24 STICKER. THEREFORE, IT WAS READ OFF AS EXPIRING AT THE END OF THE MONTH. WHEN STAFF REALIZED THE AFFECTED DEVICE HAD ACTUALLY EXPIRED ON THE 11TH, IT HAD ALREADY BEEN INTRODUCED INTO THE PATIENT, AND THE PHYSICIAN MADE THE DECISION TO DEPLOY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18902592 ↗
• MalfunctionApr 13, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. AFTER WIRING AND PRE-DILATATION, THE LESION IN A VEIN GRAFT WAS SUCCESSFULLY CROSSED. WHILE PULLING THE DEVICE BACK TO RE-POSITION, A SLIGHT CATCH WAS FELT. AT THIS POINT THE DEVICE WOULD NO LONGER ADVANCE. THE DEVICE WAS WITHDRAWN, AND IT WAS DETECTED THAT THE STENT WAS DISLODGED. THE EQUIPMENT WAS LEFT INSIDE THE BODY AND THE PATIENT WAS TRANSFERRED TO SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 14103640 ↗