Orsiro Mission 4/26/140Recalls & 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
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07640130456167), received between Oct 17, 2023 and Jul 22, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Failure to Advance” (3 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 Advance3
- Device Dislodged or Dislocated1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 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 25904400 ↗MalfunctionApr 10, 2026Failure to Advance
THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION IN A MODERATELY TO SEVERELY TORTUOUS SEGMENT OF THE PROXIMAL OM. 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 24838552 ↗MalfunctionJan 27, 2026Failure to Advance
THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION WITH 80 % STENOSIS DEGREE IN A MODERATELY TORTUOUS SEGMENT OF THE OSTIAL LM. 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 24188025 ↗MalfunctionApr 23, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN A MILDLY TORTUOUS PART OF THE OSTIAL RCA. DESPITE PRE-DILATATION, IT WAS NOT POSSIBLE TO ADVANCE THE DEVICE THROUGH THE LESION. THE STENT SYSTEM WAS REMOVED, A GUIDELINER WAS INSERTED AND IT WAS ATTEMPTED TO RE-INSERT THE ORSIRO MISSION, BUT IT WAS NOTICED THAT THERE WAS NO STENT ON THE BALLOON. THE CATHETER WAS REMOVED, AND THE STENT WAS FOUND STILL ON THE BALLOON BUT DISLODGED APPROX. 5-8 MM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21894482 ↗MalfunctionOct 17, 2023Material Deformation; Material Deformation
AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF THE RCA. A STENT DEFORMATION WAS NOTICED BEFORE THE DEVICE WAS INSERTED INTO THE PATIENTS BODY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17953899 ↗
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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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