Orsiro Mission 3.5/40/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07640130456334), received between Dec 2, 2025 and May 22, 2026 — classified as 6 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.

• MalfunctionMay 22, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION IN A MODERATELY TORTUOUS SEGMENT OF THE MEDIAL LAD. 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 25254568 ↗
• MalfunctionApr 14, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (70 % STENOSIS DEGREE) IN A MILDLY TORTUOUS SEGMENT OF THE MEDIAL TO DISTAL RCA. A PRE-DILATION OF THE LESION WAS PER-FORMED. 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 24870958 ↗
• MalfunctionMar 17, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION IN A SEVERELY TORTUOUS SEGMENT OF THE PROXIMAL 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 24615210 ↗
• MalfunctionMar 16, 2026Device Dislodged or Dislocated

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (90% STENOSIS DEGREE) IN A SEVERELY TORTUOUS SEGMENT OF THE MID RCA. DURING STENT PLACEMENT IN THE MID-RCA, RESISTANCE WAS FELT. AND IT WAS NOTED THAT THE STENT HAD BEEN SHIFTED DISTALLY. WHEN ATTEMPTING TO REPOSITION AND FURTHER ADVANCEMENT, IT SEEMED THAT THE STENT PULLED EVEN MORE. UPON ANGIOGRAPHIC INSPECTION, IT WAS NOTICED THAT THE STENT WAS NO LONGER ALIGNED WITH THE MARKER BANDS ON THE CATHETER, AND THAT THE STENT WAS DISTAL TO WHERE THE BALLOON CATHETER SAT. TO PREVENT EMBOLIZATION, THE STENT WAS PARTIALLY EXPANDED AT ITS CURRENT POSITION. THEN NON-COMPLIANT BALLOONS WERE USED TO FULLY DILATE AND ADAPT THE STENT. A SECOND STENT WAS PLACED DISTALLY TO COMPLETE THE TREATMENT OF THE LESION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24604787 ↗
• MalfunctionMar 6, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT IN A SEGMENT OF THE PROXIMAL RCA. 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 24529523 ↗
• MalfunctionDec 2, 2025Failure to Advance; Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM COULD NOT CROSS A PRE-DILATED LESION IN THE RCA. ANOTHER 3.5/40 ORSIRO MISSION WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23692377 ↗