Orsiro Mission 4/15/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07640130455986), received between Dec 7, 2021 and Jun 24, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (4 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 16, 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.

• MalfunctionJun 24, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF AN UNSPECIFIED LESION IN A 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. THE COMPLAINT DEVICE WAS NOT RETURNED FROM THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25604239 ↗
• MalfunctionFeb 3, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (80 % STENOSIS DEGREE) IN A MODERATELY TORTUOUS PART OF THE MID RCA. THE LESION WAS PRE-DILATED, AND THE AFFECTED ORSIRO MISSION WAS INTRODUCED INTO THE PATIENT'S BODY BUT WAS UNABLE TO CROSS THE LESION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24243129 ↗
• MalfunctionJan 8, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION IN A BIFURCATION OF THE PROXIMAL LAD. A PREDILATION OF THE LESION WAS PERFORMED. IN ORDER TO PERFORM A DK-CRUSH TECHNIQUE, 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 24001089 ↗
• MalfunctionDec 4, 2025Failure to Advance; Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. THE DEVICE FAILED TO CROSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23713032 ↗
• MalfunctionDec 7, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED TO TREAT A LESION IN THE VESSEL SEGMENT MID SVG TO OM. AFTER PLACING THE FIRST STENT IN THE MID SVG, A 2ND STENT WAS SUPPOSED TO BE POSITIONED DISTAL TO THE 1ST STENT BUT COULD NOT PASS THE FIRST STENT. NO INFORMATION ABOUT A POSSIBLE POST-DILATATION OF THE 1ST STENT WAS OBTAINED. IN THE FURTHER COURSE OF THE TREATMENT, A GUIDELINER EXTENSION CATHETER WAS USED FOR EXTRA SUPPORT, BUT THE 2ND STENT COULD STILL NOT PASS AND WAS REMOVED. AFTER REMOVAL, IT WAS DETECTED THAT THE 2ND STENT WAS DISLODGED. THE STENT COULD BE SUCCESSFULLY RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12953730 ↗