Orsiro Mission 3.5/13/140Recalls & 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 07640130455917), received between Jan 19, 2023 and Feb 3, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated1
- Failure to Advance1
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.
MalfunctionFeb 3, 2026Failure to Advance
THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION (80 % STENOSIS DEGREE) IN A MODERATELY TORTUOUS PART OF THE MID RCA. IT IS UNKNOWN IF A PRE-DILATION WAS PERFORMED. THE AFFECTED ORSIRO MISSION WAS INTRODUCED INTO THE PATIENT'S BODY BUT WAS UNABLE TO CROSS THE LESION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24243123 ↗MalfunctionJan 19, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. WHILE USING THE ORSIRO MISSION, THE STENT CAME OFF OF THE BALLOON IN THE BODY. A PERSON FROM STAFF, WHO WERE PRESENT DURING INTERVENTION, MENTIONED THAT THE SCRUB PERSON HAD NOT YET GONE NEGATIVE FOR PREP. ANOTHER BALLOON WAS USED TO RETRIEVE THE DISLODGED STENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16206011 ↗
Other Coronary drug-eluting stent devices
- SYNERGY™ H7493926038300Boston Scientific Corporation · Coronary drug-eluting stent8 deaths124 reports
- SYNERGY™ H7493926016300Boston Scientific Corporation · Coronary drug-eluting stent7 deaths106 reports
- SYNERGY™ H7493926020300Boston Scientific Corporation · Coronary drug-eluting stent9 deaths90 reports
- SYNERGY™ H7493926016250Boston Scientific Corporation · Coronary drug-eluting stent6 deaths82 reports
- XIENCE Sierra™ 1550350-33Abbott Vascular Inc. · Coronary drug-eluting stent1 recall32 reports
- Resolute Onyx™ RONYX30022UXMedtronic, Inc. · Coronary drug-eluting stent6 deaths76 reports
- SYNERGY™ H7493926024300Boston Scientific Corporation · Coronary drug-eluting stent3 deaths75 reports
- Resolute Onyx™ RONYX30015UXMedtronic, Inc. · Coronary drug-eluting stent3 deaths73 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page