Orsiro Mission 2.75/15/140Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07640130455955), received between Jun 27, 2023 and Jul 10, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Failure to Advance” (2 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 Advance2
- Device Dislodged or Dislocated1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 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 MODERATELY CALCIFIED LESION (90 % STENOSIS DEGREE) IN A MODERATELY TORTUOUS PART OF THE PROXIMAL LAD. THE LESION WAS PRE-DILATED, AND THE AFFECTED DEVICE WAS INTRODUCED INTO THE PATIENT'S BODY BUT COULD NOT CROSS THE LESION. NO STENT WAS IMPLANTED. 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 25778131 ↗MalfunctionMar 24, 2026Failure to Advance
THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION IN A MODERATELY 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 24679010 ↗MalfunctionJun 27, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
WHEN ATTEMPTING TO TREAT A LESION IN THE CX ATRIOVENTRICULAR GROOVE, THE STENT ADVANCED 2/3 THROUGH THE LESION, THEN HYPOTUBE SNAPPED IN TUOHY ADAPTER. THE GUIDELINER WAS TAKEN OUT, AND THE STENT WAS TRIED TO BE WITHDRAWN, BUT WAS WITHHELD ON AN OLD STENT. EVERYTHING WAS PULLED OUT EXCEPT THE STENT WAS FLOATING IN THE CX. THE STENT WAS ADAPTED TO THE VESSEL WALL WITH A NC BALLOON. NEVER REDELIVERED A NEW STENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17214026 ↗
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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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