Orsiro Mission 2.5/26/140Recalls & reported problems
Biotronik AG · Class 3 · Implant
All models of Orsiro Mission (49)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07640130456129), received between Oct 25, 2022 and Jul 21, 2026 — classified as 8 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.
Reports received per month
Most reported problems
Device problems
- Failure to Advance4
- Device Dislodged or Dislocated3
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 21, 2026Failure to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25885277 ↗MalfunctionJul 21, 2026Failure to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25885276 ↗MalfunctionJul 7, 2026Failure to Advance
THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (90 % STENOSIS DEGREE) IN A MODERATELY TORTUOUS 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 25729857 ↗MalfunctionFeb 3, 2026Failure to Advance
THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION IN THE MID LAD (90 % STENOSIS DEGREE). THE LESION WAS PRE-DILATED WITH AN 2.0 X 8 MM BALLOON. THE AFFECTED ORSIRO MISSION WAS INTRODUCED INTO THE PATIENT'S BUT COULD NOT CROSS THE LESION. EVENTUALLY, AN ORSIRO MISSION 2.5/22 WAS ABLE TO CROSS AND SUCCESSFULLY IMPLANTED. POST-DILATION WAS PERFORMED WITH A 3.0 MM BALLOON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24243130 ↗MalfunctionJan 13, 2026Material Deformation
THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (90% STENOSIS DEGREE) IN A MODERATELY TORTUOUS SEGMENT OF THE PROXIMAL RCA. AFTER PRE-DILATATION AND USING A GUIDELINER, THE ORSIRO MISSION COULD NOT CROSS THE LESION. THE STENT FRAYED UPON REMOVAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24050720 ↗MalfunctionMar 30, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. UPON REMOVAL OF THE STYLET, THE STENT CAME OFF THE BALLOON. IT WAS STANDARD OPERATING PROCEDURE OPENING AND REMOVING THE STENT FROM THE PACKAGING AND PROTECTIVE HOOP. THIS EVENT OCCURRED OUTSIDE OF THE PATIENT AND THEREFORE THE PATIENT WAS UNHARMED. A SECOND STENT WAS SELECTED AND DEPLOYED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16645954 ↗MalfunctionOct 25, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (80 PERCENT STENOSIS DEGREE) IN THE MODERATELY TORTUOUS MID LAD. IT WAS ATTEMPTED TO CROSS A CHALLENGING LESION IN THE LAD WITH ORSIRO MISSION STENT SYSTEMS AND THE STENTS BECAME DISLODGED. THIS HAPPENED WITH TWO STENTS OF SAME SIZE AND SAME LOT AND IS MORE ATTRIBUTABLE TO THE PROPERTIES OF THE LESION. THE STENTS WERE REMOVED WITH NO COMPLICATION. THIS IS TWO OF TWO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15670810 ↗MalfunctionOct 25, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (80 PERCENT STENOSIS DEGREE) IN THE MODERATELY TORTUOUS MID LAD. IT WAS ATTEMPTED TO CROSS A CHALLENGING LESION IN THE LAD WITH ORSIRO MISSION STENT SYSTEMS AND THE STENTS BECAME DISLODGED. THIS HAPPENED WITH TWO STENTS OF SAME SIZE AND SAME LOT AND IS MORE ATTRIBUTABLE TO THE PROPERTIES OF THE LESION. THE STENTS WERE REMOVED WITH NO COMPLICATION. THIS IS ONE OF TWO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15670732 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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