Orsiro Mission 4/13/140Recalls & 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 07640130455924), received between Nov 2, 2023 and Apr 10, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure to Advance” (1 report).
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 Advance1
- Fracture1
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.
MalfunctionApr 10, 2026Failure to Advance
THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (85 % STENOSIS DEGREE) IN A SEVERELY TORTUOUS SEGMENT OF THE MEDIAL 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24843168 ↗MalfunctionNov 2, 2023Fracture; Fracture
AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. WHEN CONNECTING INFLATION DEVICE TO END OF STENT CATHETER (HUB) IT SHEARED OFF FROM THE SHAFT. THIS OCCURRED OUTSIDE OF THE PATIENT AND WAS NEVER USED. AFTER ADDITIONAL CORRESPONDENCE WITH THE LOCAL STAFF, IT WAS CLARIFIED THAT THE ACTUAL COMPLAINT EVENT IS THAT THE HYPOTUBE FRACTURED WHILE CONNECTING THE INFLATION DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18057843 ↗
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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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