Orsiro Mission 2.25/18/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07640130455993), received between Oct 28, 2022 and May 5, 2026 — classified as 9 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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (80 % STENOSIS DEGREE) IN A MILDLY TORTUOUS SEGMENT OF THE MEDIAL 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 25080472 ↗
• MalfunctionApr 22, 2026Material Deformation

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF THE D1. THE STENT WAS "CRACKED" BEFORE INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24949818 ↗
• MalfunctionApr 14, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A UNCALCIFIED LESION (90 % STENOSIS DEGREE) IN A MODERATELY TORTUOUS SEGMENT OF THE MEDIAL OM1. 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 24870950 ↗
• MalfunctionApr 10, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION IN AN UNSPECIFIED 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 24838551 ↗
• MalfunctionDec 23, 2025Failure to Advance; Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION WITH 99 % STENOSIS DEGREE IN A SEGMENT OF THE PROXIMAL PDA. 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 THE LESION USING A 2.25/13 ORSIRO MISSION. THE COMPLAINT DEVICE WAS DISCARDED AT THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23874644 ↗
• MalfunctionJan 20, 2025Material Deformation; Material Deformation

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN A MODERATE PART OF THE PROXIMAL OM. THE STENT WAS INTRODUCED INTO THE PATIENT BODY ALONG WITH A GUIDE EXTENSION CATHETER AND WIRE. THE LESION WAS NOT CROSSED. THE STENT AND ALL OTHER EQUIPMENT WERE REMOVED. UPON REMOVAL IT WAS NOTED THAT THE STENT HAD BECOME DAMAGED. A NEW STENT WAS ACQUIRED AND DEPLOYED ALONG WITH ALL OTHER NEW EQUIPMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21193213 ↗
• MalfunctionApr 12, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF AN OSTIAL/PROXIMAL LAD 90-PLUS PERCENT LESION WITH SEVERE CALCIFICATION. PRE-DILATATION WAS DONE, AND IT WAS ATTEMPTED TO CROSS WITH THE ORSIRO MISSION THROUGH A 7FR GUIDELINER. SIGNIFICANT RESISTANCE WAS ENCOUNTERED DURING MULTIPLE ATTEMPTS TO CROSS, THE DEVICE DID NOT CROSS. THE ORSIRO MISSION WAS WITHDRAWN, IT WAS NOTICED THAT THE STENT WAS NO LONGER ON THE DELIVERY SYSTEM. IMAGING REVEALED THE STENT WAS LOOSE ON THE GUIDE WIRE IN THE LEFT MAIN. A SMALL DIAMETER BALLOON WAS INSERTED OVER THE GW AND PLACED IN THE PROXIMAL SECTION OF THE DES, LOW ATM INFLATION, DES/BALLOON/GUIDE ALL WAS WITHDRAWN. THE CASE WAS COMPLETED WITH A NEW GUIDE SYSTEM INSERTED AND A COMPETITIVE STENT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16724976 ↗
• MalfunctionMar 7, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THERE WAS A HIGHLY CALCIFIED LESION WHERE A COMPETITOR STENT WOULD NOT CROSS. THEN THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED WHICH CROSSED THE LESION, BUT NOT FULLY. THE ORSIRO MISSION WAS WITHDRAWN THROUGH THE GUIDE, AND IT WAS NOTICED THAT THE STENT WAS NOT ON THE BALLOON, BUT IN THE BODY. THE STENT WAS RETRIEVED. THE INTERVENTION WAS COMPLETED AND THE PATIENT WAS DISCHARGED WITH NO ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16497470 ↗
• MalfunctionOct 28, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. THE PHYSICIAN INTENDED TO TREAT A MILDLY CALCIFIED LESION (100 PERCENT STENOSIS DEGREE, VESSEL REFERENCE DIAMETER 2.5 MM, LESION LENGTH 18 MM) IN A MILDLY TORTUOUS PART OF THE DISTAL LCX. IT IS NOTED THAT THERE WAS AN OLDER STENT MORE PROXIMAL TO THE LESION WITH A MILD-MODERATE IN-STENT RESTENOSIS. AFTER PRE-DILATION WITH A 2.0 X 12 MM BALLOON AND SUBSEQUENT THROMBECTOMY, THE COMPLAINT INSTRUMENT WAS INTRODUCED AND ADVANCED TOWARDS THE TARGET LESION IN THE DISTAL LCX BUT COULD NOT CROSS THE PREVIOUSLY IMPLANTED STENT IN THE MID LCX. THE COMPLAINT INSTRUMENT WAS WITHDRAWN. HOWEVER, AFTER WITHDRAWAL OF THE COMPLAINT INSTRUMENT IT WAS NOTICED THAT THE STENT HAD DISLODGED FROM THE BALLOON. THE DISLODGED STENT WAS LOCATED IN THE PROXIMAL LCX WHERE IT WAS ADAPTED TO THE VESSEL WALL WITH A 3.5 X 12 MM NC BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15690790 ↗