Orsiro Mission 3.5/9/140Recalls & 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 07640130455856), received between Jan 8, 2026 and Jul 21, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Failure to Advance” (5 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 Advance5
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 21, 2026Failure to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25885275 ↗MalfunctionMay 22, 2026Failure to Advance
THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION (90 % STENOSIS DEGREE) 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. EVEN AFTER INSERTING A GUIDING EXTENSION CATHETER, THE PHYSICIAN WAS UNABLE TO CROSS THE LESION WITH THE COMPLAINT DEVICE STENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25255099 ↗MalfunctionApr 10, 2026Failure to Advance
THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION IN A SEGMENT OF AN UNDEFINED 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 24838793 ↗MalfunctionFeb 13, 2026Failure to Advance
THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION IN A MILDLY TORTUOUS SEGMENT OF THE OSTIAL LCX. 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 DEVICE WAS REMOVED WITHOUT ANY HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24332222 ↗MalfunctionJan 8, 2026Failure to Advance
THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION (90 % STENOSIS DEGREE) IN A MODERATELY TORTUOUS SEGMENT OF THE MEDIAL TO DISTAL RCA. IT IS UNKNOWN IF A PRE-DILATION OF THE LESION WAS PERFORMED. UNDER USE OF A GUIDELINER THE AFFECTED DEVICE WAS INTRODUCED INTO THE PATIENT'S BODY BUT COULD NOT CROSS THE LESION. THE COMPLAINT DEVICE WAS DISCARDED AT THE HOSPITAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24001086 ↗
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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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