Orsiro Mission 3.5/18/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07640130456037), received between Jul 19, 2022 and Jul 22, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (6 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.

• MalfunctionJul 22, 2026Failure to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25904402 ↗
• MalfunctionApr 22, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION IN A SEVERELY TORTUOUS SEGMENT OF THE DISTAL LCX. THE DEVICE WAS UNABLE TO CROSS AN OLD STENT (ISR) PROXIMAL TO THE TARGET LESION "DUE TO WIRE BIAS AGAINST THE OLD STENT STRUTS".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24949817 ↗
• MalfunctionApr 14, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (70 % STENOSIS DEGREE) IN A MILDLY TORTUOUS SEGMENT OF THE MEDIAL TO DISTAL RCA. 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 24870975 ↗
• MalfunctionFeb 13, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A CALCIFIED LESION IN A SEGMENT OF THE MEDIAL RCA. A PRE-DILATION OF THE LESION WAS PERFORMED. THE AFFECTED DEVICE WAS INTRODUCED INTO THE PATIENT'S BODY BUT COULD NOT CROSS THE LESION. IT IS MENTIONED, THAT "THERE WAS ANOTHER STENOSIS MORE PROXIMAL THAT WAS NOT APPRECIATED". AN ADDITIONAL LESION PREPARATION WAS PERFORMED USING SHOCKWAVE TO THE PROXIMAL TO MEDIAL RCA. THEREAFTER IT WAS POSSIBLE TO CROSS THE LESION USING A LONGER ORSIRO MISSION WITHOUT ISSUE TO TREAT THE ENTIRE LENGTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24332226 ↗
• MalfunctionDec 23, 2025Failure to Advance; Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. PRE-DILATION 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 SMALLER ORSIRO MISSION". THE COMPLAINT DEVICE WAS DISCARDED AT THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23874821 ↗
• MalfunctionJun 19, 2025Use of Device Problem; Use of Device Problem

  ON (B)(6) 2025, THIS DEVICE WAS INTENDED TO TREAT A LESION (100 PERCENT STENOSIS DEGREE) IN THE MID LAD / OM. THE LESION WAS PRE-DILATED. THEREAFTER, THE AFFECTED ORSIRO MISSION (EXPIRY DATE 26.APR.2025) WAS INTRODUCED INTO THE PATIENTS BODY AND SUCCESSFULLY IMPLANTED WITHOUT INCIDENCE, HOWEVER, 32 DAYS AFTER THE EXPIRY DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22292233 ↗
• MalfunctionJan 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ORSIRO MISSION DRUG-ELUTING STENT SYSTEMS WERE SELECTED FOR TREATMENT OF A MILDLY CALCIFIED TOTAL OCCLUSION IN A SEVERELY TORTUOUS PART OF THE PROXIMAL RCA. AFTER PREDILATATION AND A SUCCESSFUL PLACEMENT OF A 3.5X13 ORSIRO, IT WAS ATTEMPTED TO PLACE THE COMPLAINT DEVICE, BUT THIS WAS NOT SUCCESSFUL. UPON THE ATTEMPT TO REMOVE IT, THE STENT BECAME DISLODGED, AND IT WAS NOT POSSIBLE TO LOCATE IT ANYMORE. IT WAS CONFIRMED THAT THE STENT DID NOT REMAIN IN THE BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21277988 ↗
• MalfunctionNov 19, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING INSERTION IT WAS NOTICED THAT THE ORSIRO MISSION STENT WAS NOT CENTERED ON THE DELIVERY BALLOON. THUS, THE DEVICE WAS REMOVED SUCCESSFULLY AND FIVE FURTHER STENTS WERE IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20724323 ↗
• MalfunctionMay 7, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. THE STENT HAD DISLODGED FROM THE BALLOON. APPARENTLY, IT WAS POSSIBLE TO PUSH THE STENT TO THE CORRECT LOCATION, SLIP A SMALL BALLOON INSIDE THE STENT AND DEPLOY IT. NO FURTHER ISSUES, THE PATIENT IS DOING FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19264582 ↗
• MalfunctionNov 22, 2022Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION IN THE MODERATELY TORTUOUS MID LAD. IT WAS NOT POSSIBLE TO CROSS THE LESION WITH THE ORSIRO MISSION. WHEN REMOVING IT FROM THE VESSEL THE STENT BECAME STUCK ON A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). AS IT WAS TRIED TO FREE THE STENT FROM THE TAVR, IT CAME OFF THE BALLOON. IT WAS POSSIBLE TO SNARE AND REMOVE THE ORSIRO MISSION FROM THE PATIENT. THE INTERVENTION WAS COMPLETED WITH ANOTHER STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15848640 ↗
• MalfunctionJul 19, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. DURING THE PROCEDURE, THE STENT CAME OFF THE DELIVERY SYSTEM WHILE TRYING TO DEPLOY IT IN THE MID CX..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15056942 ↗