Orsiro Mission 2.5/40/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07640130456303), received between Mar 23, 2022 and Jul 7, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (8 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (85 % STENOSIS DEGREE) IN A MILDLY TORTUOUS SEGMENT OF THE PROXIMAL LCX. 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 CALCIFICATION). THE PHYSICIAN WAS ABLE TO CROSS THE LESION USING ANOTHER ORSIRO MISSION WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25729856 ↗
• MalfunctionMay 5, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED CTO LESION (100 % STENOSIS DEGREE) IN A SEVERELY TORTUOUS SEG-MENT OF THE RIM. 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 25080468 ↗
• 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 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 24615209 ↗
• MalfunctionMar 6, 2026Device Dislodged or Dislocated

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION. OUTSIDE PATIENT, THE STENT SLIPPED OFF THE BALLOON INSIDE THE HEMOSTASIS VALVE. THE PATIENT DIED DUE TO COMPLICATIONS RELATED TO A COMPLEX PCI. THE PATIENT'S DEATH WAS CLASSIFIED BY THE HOSPITAL AS NOT BEING CAUSED BY THE DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 24528816 ↗
• MalfunctionFeb 27, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (80 % STENOSIS DEGREE) IN A MODERATELY TORTUOUS PART OF THE MID LAD. THE LESION WAS PRE-DILATED, AND 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 24469204 ↗
• MalfunctionJan 23, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION IN A MODERATELY TORTUOUS ENTIRE CORONARY VESSEL FROM OSTIAL TO DISTAL. A PRE-DILATION OF THE LESION WAS PERFORMED. THE AFFECTED DEVICE WAS INTRODUCED INTO THE PATIENT'S BODY BUT COULD NOT CROSS THE LESION. AFTER FURTHER PRE-DILATION WAS PERFORMED, IT WAS POSSIBLE THE TO PASS AND IMPLANT TWO OTHER ORSIRO TO THE MEDIAL AND DISTAL SEGMENT OF THE VESSEL. THE TREATMENT OF THE OSTIAL SEGMENT OF THE VESSEL WILL BE RE-SCHEDULED FOR A ROTABLATOR PREPARATION OF THE LESION AND IMPLANTATION OF ANOTHER ORSIRO MISSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24159223 ↗
• MalfunctionJan 13, 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 LAD. PRE-DILATION OF THE LESION WITH COMPLIANT BALLOONS, NON-COMPLIANT BALLOONS AND SHOCKWAVE IVL WAS PERFORMED. UNDER USE OF A GUIDELINER THE AFFECTED DEVICE WAS INTRODUCED INTO THE PATIENT'S BODY BUT COULD NOT CROSS THE LESION. EVEN AFTER THE LESION WAS FURTHER PREPARED, NO STENT COULD CROSS THE LESION. IT WAS DECIDED TO RE-SCHEDULE THE PATIENT FOR ROTABLATOR TREATMENT AND ADDITIONAL STENTING. THE COMPLAINT DEVICE WAS NOT RETURNED FROM THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24050722 ↗
• MalfunctionMay 8, 2024Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (80 PERCENT STENOSIS DEGREE) IN THE MODERATELY TORTUOUS LAD. AFTER PRE-DILATATION, THE DEVICE DID NOT CROSS AND WAS REMOVED OVER THE WIRE. A STENT DEFORMATION WAS DETECTED (STENT STRUT HAD ACCORDION LIKE FORM). THE PHYSICIAN STATED THAT UPON ADVANCING THE DEVICE, HE FELT SOME RESISTANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19270541 ↗
• MalfunctionMar 4, 2024Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (STENOSIS DEGREE: 80 PERCENT) IN THE MILDLY TORTUOUS PROXIMAL L PERONEAL. THE LESION COULD NOT BE CROSSED WITH THE DEVICE. THE STENT WAS REMOVED, AND IT WAS NOTED THAT THE STENT WAS BENT ON THE DELIVERY SYSTEM AND WAS UNABLE TO BE RE-INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18833593 ↗
• MalfunctionDec 21, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE ORSIRO MISSION DRUG ELUTING STENT DISLODGED OFF THE BALLOON WHEN INTRODUCING IT INTO THE COPILOT. THE SECOND STENT WENT IN WITHOUT ISSUE. THE PATIENT WAS NOT HARMED WHEN THIS OCCURRED AS THE INCIDENT WAS DISCOVERED BY THE PHYSICIAN IMMEDIATELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18374299 ↗
• MalfunctionDec 14, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. THE STENT CAME OFF THE BALLOON WHEN STYLET AND PROTECTIVE SLEEVE WERE REMOVED FROM STENT DELIVERY SYSTEM. IT WAS NOT NOTICED THAT THE STENT CAME OFF THE BALLOON BEFORE INSERTION OF THE STENT DELIVERY SYSTEM INTO THE PATIENT. NO INJURY TO PATIENT AND ANOTHER ORSIRO MISSION WITH SAME SIZE WAS PLACED IN VESSEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18331057 ↗
• MalfunctionAug 22, 2023Material Deformation; Material Deformation

  AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. THE DEVICE WOULD NOT PASS THROUGH A 6F GUIDELINER. THE DEVICE WAS WITHDRAWN, AND UPON PHYSICAL EXAM THE DISTAL TIP OF THE STENT APPEARED TO BE DEFORMED. PART OF THE STENT WAS ALSO STICKING OUT PARTLY FROM THE BALLOON, WHICH SEEMED TO BE THE PORTION THAT GOT HUNG UP INSIDE THE GUIDELINER. A NEW ORSIRO MISSION WITH SAME SIZE WAS OPENED AND ADVANCED WITHOUT ISSUE THROUGH THE SAME GUIDELINER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17594751 ↗
• MalfunctionMar 23, 2022Material Deformation; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN THE MODERATELY TORTUOUS CX. THE DEVICE COULD NOT CROSS THE LESION AND WAS ATTEMPTED TO BE WITHDRAWN, BUT THE STENT WAS BUNCHED UP AND COULD NOT BE PULLED BACK THROUGH THE GUIDE CATHETER. EVERYTHING HAD TO BE REMOVED AND A SNARE WAS USED TO PULL THE ENTIRE STENT BALLOON OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13870639 ↗