Orsiro Mission 3/30/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07640130456204), received between Nov 1, 2023 and May 26, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (9 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION IN A SEGMENT OF THE MEDIAL TO DISTAL SUPERIOR MESENTERIC ARTERY (SMA). 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. THE PHYSICIAN WAS ABLE TO CROSS AND TREAT THE LESION USING A SELF-EXPANDABLE STENT-GRAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25273770 ↗
• MalfunctionMay 26, 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 MEDIAL LAD. A PRE-DILATION OF THE LESION WAS PERFORMED INCLUDING SHOCKWAVE BALLOONS. 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 25273769 ↗
• MalfunctionMay 5, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION IN A SEGMENT OF THE MEDIAL TO DISTAL 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 25079824 ↗
• MalfunctionApr 24, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION IN A MODERATELY TO SEVERELY TORTUOUS 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 24977859 ↗
• MalfunctionApr 11, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION IN A SEGMENT OF AN UNDEFINED VESSEL. 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 24851483 ↗
• MalfunctionMar 17, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (90 % STENOSIS DEGREE) IN A MODERATELY TORTUOUS SEGMENT OF THE MEDIAL LAD. 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 24616625 ↗
• MalfunctionMar 17, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION IN A MODERATELY TO SEVERELY TORTUOUS SEGMENT FROM THE PROXIMAL LCX TO THE OM2. A PRE-DILATION OF THE LESION WAS PERFORMED. THE AFFECTED DEVICE WAS INTRODUCED INTO THE PATIENT'S BODY BUT COULD NOT CROSS THE LESION "DUE TO THE SEVERE TORTUOSITY OF THE VESSEL".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24616621 ↗
• MalfunctionFeb 24, 2026Material Deformation

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION IN A SEVERELY TORTUOUS SEGMENT OF THE OSTIAL CX. WHILE INSERTING THE ORSIRO MISSION, THE STENT BUCKLED ON ITSELF, STILL ON THE BALLOON. AFTER REMOVAL FROM BODY, THE STENT IS STILL INTACT ON BALLOON. A STENT FROM ANOTHER MANUFACTURER WAS USED TO COMPLETE THE INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24427059 ↗
• MalfunctionJan 9, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION (80 % STENOSIS DEGREE) IN A MILDLY TORTUOUS SEGMENT OF THE MEDIAL RCA. PRE-DILATION OF THE LESION WAS PERFORMED. THE AFFECTED DEVICE WAS INTRODUCED INTO THE PATIENT'S BODY BUT COULD NOT CROSS THE LESION. THE COMPLAINT DEVICE WAS DISCARDED AT THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24017600 ↗
• MalfunctionNov 26, 2025Material Deformation; Material Deformation

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF THE MID TO DISTAL LAD. DURING THE REMOVAL OF THE STENT COVER OF THE ORSIRO MISSION THERE WAS RESISTANCE. THE STENT WAS DISCOVERED TO BE DAMAGED, AND THE BALLOON APPEARED TO BE INFLATED ON THE END OF THE STENT. ANOTHER ORSIRO MISSION WAS USED WITHOUT ANY ISSUES. THE PATIENT HAD NO COMPLICATIONS DURING OR POST PROCEDURE AND WAS DISCHARGED HOME FROM THE HOSPITAL THE NEXT DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23653769 ↗
• MalfunctionNov 12, 2025Failure to Advance; Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (96 % STENOSIS DEGREE) IN A SEVERELY TORTUOUS SEGMENT OF THE MEDIAL RCA. AFTER PRE-DILATION OF THE LESION, 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 23530643 ↗
• MalfunctionNov 1, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A PREDILATED LESION. DURING INTERVENTION, A NEW HEMOSTATIC VALVE WAS USED. THE VALVE WAS NOT FULLY OPENED AND STRIPPED THE STENT OFF WHILE ENTERING THE HEMOSTATIC VALVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18048161 ↗