Orsiro Mission 2.5/18/140Recalls & 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 07640130456006), received between Jan 29, 2024 and Mar 24, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated3
- Failure to Advance2
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.
MalfunctionMar 24, 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 DISTAL LAD. 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 TARGET LESION WAS FURTHER PRE-DILATED BUT IT WAS STILL NOT POSSIBLE TO CROSS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24672687 ↗MalfunctionJan 14, 2026Failure to Advance
THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATE CALCIFIED LESION IN A MILDLY TORTUOS PART OFT THE PROXIMAL LCX. DEVICE COULD NOT CROSS THE LESION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24066684 ↗MalfunctionAug 20, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. DURING INTRODUCTION, RESISTANCE WAS FELT, AND THE DEVICE WAS WITHDRAWN. THE STENT WAS FOUND IN THE TUOHY. ANOTHER STENT WAS USED, AND THE INTERVENTION WAS COMPLETED WITHOUT ANY ISSUES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20006739 ↗MalfunctionFeb 20, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION IN THE RCA. THE STENT CAME OFF THE BALLOON CATHETER IN THE GUIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18737813 ↗MalfunctionJan 29, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. DURING INTRODUCTION OF THE ORSIRO MISSION OVER THE WIRE INTO THE MAIN INTRODUCER SHEATH, THE STENT CAME OFF THE BALLOON. DISLODGEMENT WAS NOTICED AND THE DEVICE WAS NOT INTRODUCED INTO THE PATIENTS BODY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18603281 ↗
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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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