Orsiro Mission 3/13/140Recalls & 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
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07640130455900), received between Apr 7, 2022 and Jun 24, 2026 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Failure to Advance” (6 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 Advance6
- Device Dislodged or Dislocated1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 24, 2026Failure to Advance
THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION WITH 60 % STENOSIS DEGREE IN A SEGMENT OF AN UNSPECIFIED MEDIAL 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. THE COMPLAINT DEVICE WAS NOT RETURNED FROM THE HOSPITAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25604240 ↗MalfunctionMay 22, 2026Failure to Advance
THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (70 % STENOSIS DEGREE) IN A SEGMENT OF A DISTAL VESSEL. 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 25252697 ↗MalfunctionMar 24, 2026Failure to Advance
THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (90 % STENOSIS DEGREE) IN A SEVERELY TORTUOUS SEGMENT OF THE MEDIAL 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24679379 ↗MalfunctionMar 6, 2026Failure to Advance
THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION IN A SEGMENT OF THE LAD. IT IS UNCLEAR 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 24529521 ↗MalfunctionFeb 27, 2026Failure to Advance
THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION (80 % STENOSIS DEGREE) IN A MILDLY TORTUOUS PART OF THE MID LCX. THE LESION WAS PRE-DILATED, AND 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 24469203 ↗MalfunctionJun 3, 2025Material Deformation; Material Deformation
THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION IN A SEVERELY TORTUOUS PART OF THE OSTIAL LCX. AFTER PREDILATION OF THE LESION, THE AFFECTED ORSIRO MISSION WAS INTRODUCED INTO THE PATIENTS BODY DURING WHICH THE CATHETER SHAFT WAS DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22132996 ↗MalfunctionJul 19, 2022Failure to Advance; Failure to Advance
AN ORSIRO MISSION US DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERE CALCIFIED LESION. THE STENT SYSTEM WAS RE-ADVANCED A SECOND TIME AFTER BALLOONING BUT COULD NOT PASS THE LESION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15056746 ↗MalfunctionApr 7, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION IN THE CX. DESPITE PRE-DILATATION THE LESION COULD NOT BE CROSSED, AND THE DEVICE WAS REMOVED. DURING WITHDRAWAL THE STENT SEEMED TO CATCH ON A PREVIOUSLY PLACED STENT FROM A PAST PROCEDURE AND DISLODGED, BUT IT WAS POSSIBLE TO GET A SMALL BALLOON INTO THE STENT AND ADAPT IT TO THE VESSEL WALL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14047478 ↗
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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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