Orsiro Mission 2.75/35/140Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07640130456259), received between Jun 9, 2026 and Sep 29, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure to Advance” (2 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 Advance2
- Device Dislodged or Dislocated1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Failure to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927970 ↗MalfunctionJun 9, 2026Failure to Advance; Device Dislodged or Dislocated
THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (99% STENOSIS DEGREE) IN A MODERATELY TORTUOUS SEGMENT OF A LAD BIFURCATION. AFTER THE DEVICE HAD BEEN INSERTED INTO THE HEMOSTATIC VALVE, IT COULD NOT BE ADVANCED ANY FURTHER, SO THE STENT DELIVERY SYSTEM WAS REMOVED. WHEN ATTEMPTING TO ADVANCE A BALLOON, IT BECAME APPARENT THAT THE STENT HAD BECOME DISLODGED IN THE HEMOSTATIC VALVE. THE STENT WAS REMOVED FROM THE VALVE, AND THE PROCEDURE CONTINUED WITHOUT ANY HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25442847 ↗
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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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