Orsiro Mission 3/15/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07640130455962), received between Mar 3, 2022 and Apr 29, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY TO SEVERELY CALCIFIED LESION (98 % 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 25025072 ↗
• MalfunctionMar 24, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (80 % STENOSIS DEGREE) IN A SEVERELY TORTUOUS SEGMENT OF THE MEDIAL OM1. A PRE-DILATION OF THE LESION WAS PERFORMED. UNDER USE OF A GUIDELINER GUIDING EXTENSION CATHETER AND A BUDDY WIRE 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 24678878 ↗
• MalfunctionMar 11, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION IN A SEGMENT OF THE PROXIMAL LCX. 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 24566322 ↗
• MalfunctionFeb 20, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION IN AN UNKNOWN SEGMENT OF A CORONARY ARTERY. 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 24399556 ↗
• MalfunctionFeb 20, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION (90 % STENOSIS DEGREE) IN A MILDLY TORTUOUS SEGMENT OF THE MEDIAL LAD. 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 24399555 ↗
• MalfunctionJan 23, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION IN A SEGMENT OF THE MEDIAL LAD. THE AFFECTED DEVICE WAS INTRODUCED INTO THE PATIENT'S BODY BUT COULD NOT CROSS THE LESION. IT WAS POSSIBLE TO CROSS THE LESION USING ANOTHER MANUFACTURERS STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24159220 ↗
• MalfunctionNov 19, 2025Failure to Advance; Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (15% STENOSIS DEGREE) IN A MODERATELY TORTUOUS PART OF THE MID CX. THE DEVICE DID NOT CROSS LEFT MAIN WITH ACUTE ANGLE TO CX WITH TORTUOSITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23591206 ↗
• MalfunctionJan 22, 2024Material Deformation; Material Deformation

  AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. THE DEVICE WAS ADVANCED AND WOULD NOT CROSS A MODERATELY CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN A SEVERELY TORTUOUS PART OF THE MID RCA. ADDITIONAL DILATATION WAS PERFORMED. SINCE THE EDGE OF THIS STENT WAS LIFTED UP, ANOTHER 3.0/15 ORSIRO MISSION STENT WAS USED AND WAS SUCCESSFULLY PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18558251 ↗
• MalfunctionApr 13, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. THE ORSIRO MISSION US STENT DISLODGED FROM THE BALLOON DURING THE ATTEMPT TO CROSS THE LESION. IT WAS POSSIBLE TO LOCATE THE STENT AND THE DELIVERY BALLOON WAS USED TO GO IN THE STENT AND DEPLOY THE STENT IN PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14103647 ↗
• MalfunctionMar 3, 2022Material Deformation; Material Deformation

  AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN THE MILDLY TORTUOUS MID RCA. IT WAS ATTEMPTED TO IMPLANT THE ORSIRO MISSION DISTAL TO A PREVIOUSLY PLACED STENT. BUT DESPITE PRE-DILATATION, THE PREVIOUSLY IMPLANTED STENT COULD NOT BE CROSSED WITH THE DEVICE. AFTER WITHDRAWAL, A STENT DEFORMATION WAS DETECTED AT THE PROXIMAL EDGE. ANOTHER STENT WAS USED TO COMPLETE THE INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13660598 ↗