Orsiro Mission 3/22/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07640130456082), received between Mar 23, 2022 and May 22, 2026 — classified as 11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION IN A MODERATELY TORTUOUS SEGMENT OF THE MEDIAL RCA. 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 25252698 ↗
• MalfunctionMay 5, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION IN A SEVERELY TORTUOUS SEGMENT OF A DISTAL UNSPECIFIED VESSEL. 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 25079823 ↗
• MalfunctionFeb 27, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION IN THE LAD. 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 24469199 ↗
• MalfunctionJan 22, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (70 % STENOSIS DEGREE) IN A MODERATELY TORTUOUS SEGMENT OF THE MEDIAL LAD. A PRE-DILATION OF THE LESION WAS PERFORMED WITH A 3.0 MM BALLOON. THE AFFECTED DEVICE WAS INTRODUCED INTO THE PATIENT'S BODY BUT COULD NOT CROSS THE LESION. IT WAS POSSIBLE TO CROSS THE LESION BY USING ANOTHER MANUFACTURER'S STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24141969 ↗
• MalfunctionNov 26, 2025Failure to Advance; Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A VERY TORTUOUS AND CALCIFIED ANATOMY. THE DEVICE DID NOT CROSS. IT WAS TRIED TO USE A GUIDELINER AS WELL AND WOULD NOT DELIVER. ONLY BALLOONS CROSSED, NO OTHER STENTS WERE TRIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23654140 ↗
• MalfunctionMay 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (80 PERCENT STENOSIS DEGREE) IN A MODERATELY TORTUOUS PART OF THE MID LAD. THE PATIENT HAD MULTIPLE LAYERS OF STENT AND CALCIUM IN THE LEFT MAIN AND LAD. THE DEVICE WAS ADVANCED TO THE PROXIMAL LAD AND RESISTANCE WAS FELT. IT WAS DECIDED TO WITHDRAW THE STENT AND PUT A GUIDE CATHETER EXTENSION IN. WHEN THE ORSIRO MISSION DEVICE WAS REMOVED, IT WAS NOTICED THAT THE STENT WAS OFF THE BALLOON. THE STENT HAD BECOME DISLODGED IN THE LAD. IT WAS DECIDED TO CRUSH THE STENT IN THE LAD WITH ANOTHER STENT. THERE WAS NO PATIENT INJURY OR HARM. PATIENT WAS DISCHARGED HOME WITH NO COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22063379 ↗
• MalfunctionJul 10, 2024Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE COMPLAINT ORSIRO MISSION WOULD NOT CROSS LESION. WHEN REMOVING THE DEVICE FROM PATIENTS BODY, IT WAS DETECTED THAT THE DISTAL TIP OF THE DELIVERY SYSTEM WAS DAMAGED. A 2ND ORSIRO MISSION WITH SAME SIZE WAS INSERTED BUT DID NOT CROSS AGAIN (REPORTED SEPARATELY). THE DISTAL TIP WAS DAMAGED AS WELL. FINALLY, AN ORSIRO MISSION 3.0/26 WAS INSERTED, AND THE PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19709972 ↗
• MalfunctionJul 10, 2024Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE 1ST ORSIRO MISSION WOULD NOT CROSS LESION. WHEN REMOVING THE DEVICE FROM PATIENTS BODY, IT WAS DETECTED THAT THE DISTAL TIP WAS DAMAGED (REPORTED SEPARATELY). SUBSEQUENTLY, THE COMPLAINT ORSIRO MISSION WITH SAME SIZE WAS INSERT BUT DID NOT CROSS AGAIN. THE DISTAL TIP WAS DAMAGED AS WELL. FINALLY, AN ORSIRO MISSION 3.0/26 WAS INSERTED, AND THE PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19709551 ↗
• MalfunctionJun 18, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (STENOSIS DEGREE: 80 PERCENT) IN THE SEVERELY TORTUOUS BIFURCATION LAD. THE ORSIRO MISSION WAS INTRODUCED THROUGH A GUARDIAN HEMOSTASIS VALVE, BUT RESISTANCE WAS FELT, AND IT WAS ADVANCED FURTHER REGARDLESS OF THE RESISTANCE. THE STENT DELIVERY SYSTEM SUBSEQUENTLY KINKED AND WAS THEREFORE REMOVED OUT OF THE GUIDE. PRIOR TO DISCARDING THE CATHETER, IT WAS NOTICED THAT THE STENT WAS OFF THE STENT DELIVERY BALLOON AND WAS RESTING ON THE STENT DELIVERY SYSTEM CATHETER. NEITHER THE STENT, NOR THE STENT DELIVERY SYSTEM ENTERED THE PATIENT ANATOMY. THIS ALL OCCURRED INSIDE THE GUARDIAN RHC AND GUIDE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19557052 ↗
• MalfunctionFeb 1, 2024Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  AN 3.5/26 ORSIRO MISSION DRUG-ELUTING STENT WAS SUCCESSFULLY PLACED IN THE PROX. LAD. WHEN ATTEMPTING TO PLACE THE 3.0/22 ORSIRO MISSION (COMPLAINT DEVICE) THROUGH THE ALREADY IMPLANTED STENT, UNABLE TO CROSS. UNDEPLOYED STENT WAS REMOVED, AND FURTHER DILATATION WAS PERFORMED. THE UNDEPLOYED 3.0/22 ORSIRO MISSION WAS INSPECTED, AND INTEGRITY CONFIRMED AND REINSERTED IN THE PATIENT. THE 3.0/22 ORSIRO MISSION WOULD NOT CROSS THE DIAGONAL LESION. THE UNDEPLOYED STENT WAS NOT ON THE DEVICE ANYMORE, WHEN REMOVING IT AGAIN FROM PATIENTS BODY. THE STENT DISLODGED IN THE PROX. LAD/LM PORTION OF THE BODY WHICH WAS CONFIRMED WITH THE IVUS. DUE TO THE STENT DISLODGMENT THE PATIENT BEGAN TO EXPERIENCE IMMENSE CHEST PAIN AND WAS UNABLE TO REMAIN STILL. PATIENT WAS INTUBATED AND THE DISLODGED STENT WAS COVERED WITH A XIENCE DES. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2024.

  Patient problems: Chest Pain

  MAUDE report 18626576 ↗
• MalfunctionMar 23, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN THE MODERATELY TORTUOUS MID LAD. AFTER PRE-DILATAION OF THE LESION, THE DEVICE COULD NOT BE ADVANCED AND WAS REMOVED FOR FURTHER DILATATION. THEN, THE DEVICE WAS REINTRODUCED. IT DID NOT CROSS AGAIN AND THE STENT DISLODGED. THE STENT WAS NOT RETRIEVED. PATIENT HAD A BYPASS SURGERY WHICH WAS STATED AS NOT RELATED TO THE DISLODGED STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13871096 ↗