Orsiro Mission 3.5/35/140Recalls & 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
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07640130456273), received between Aug 18, 2022 and Jul 10, 2026 — classified as 7 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
- Device Dislodged or Dislocated1
- Inflation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 10, 2026Failure to Advance
THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION IN THE MID LAD. THE AFFECTED DEVICE WAS INTRODUCED INTO THE PATIENT'S BODY BUT WAS UNABLE TO CROSS THE LESION. NO PARTS REMAINED IN THE PATIENT'S BODY. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25778132 ↗MalfunctionApr 29, 2026Failure to Advance
THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY TO SEVERELY CALCIFIED LESION (98 % STENOSIS DEGREE) IN A MODERATELY TORTUOUS 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25030119 ↗MalfunctionMar 24, 2026Failure to Advance
THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION IN A SEGMENT OF AN UNSPECIFIED VESSEL. IT WAS NOT REPORTED BY THE HOSPITAL IF 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 24672233 ↗MalfunctionMar 10, 2026Failure to Advance
THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION IN A MILDLY TORTUOUS SEGMENT OF THE 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 24558631 ↗MalfunctionDec 22, 2025Failure to Advance; Failure to Advance
THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SVG. AFTER INSERTION OF THE FIRST STENT, BLOOD CLOTS WERE STILL VISIBLE, SO A SECOND STENT WAS INSERTED. ACCORDING TO THE SALES REPRESENTATIVE THE DEVICE DID NOT CROSS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23862622 ↗MalfunctionDec 19, 2024Inflation Problem; Inflation Problem
THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF THE POPLITEAL ARTERY. THE DEVICE FAILED TO INFLATE WHEN TRYING TO PLACE THE STENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20979856 ↗MalfunctionAug 18, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. THE PREDILATED LESION COULD NOT BE CROSSED WITH THE DEVICE. WHILE THE STENT WAS BEING REMOVED, IT WAS STRIPPED OFF THE BALLOON BY THE HEMOSTATIC VALVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15250841 ↗
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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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