Orsiro Mission 3/40/140Recalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07640130456327), received between Jan 18, 2023 and Nov 13, 2025 — classified as 1 injury, 3 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
- Fracture1
- Inflation Problem1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Asystole1
- Low Blood Pressure/ Hypotension1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 13, 2025Fracture; Fracture
THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION WITH 70% STENOSIS DEGREE IN THE AT. DURING PROCEDURE THE HYPOTUBE BROKE IN THE SHEATH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23540644 ↗InjuryJun 4, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
STENT SHEARED OFF THE BALLOON AND HAD TO BE SNARED FROM LEFT MAIN. AFTER THE DEVICE WAS REMOVED, AN EXTENSION CATHETER WAS INSERTED AND IT WAS PLANNED TO IMPLANT ANOTHER ORSIRO MISSION, BUT PATIENT THEN WENT ASYSTOLE AND HYPOTENSIVE. CPR/ACLS WAS INITIATED, AND THE PATIENT WAS INTUBATED. AN IMPELLA WAS THEN PLACED AS WELL. PATIENT WAS GIVEN A SECOND ORSIRO MISSION STENT WHICH WAS DEPLOYED SUCCESSFULLY, AND THE PATIENT WENT HOME IN GOOD HEALTH.
Patient problems: Asystole; Low Blood Pressure/ Hypotension
MAUDE report 19460959 ↗MalfunctionOct 25, 2023Inflation Problem; Inflation Problem
AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION IN THE MID CX. THE STENT WAS NOT DEPLOYING AND WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18004690 ↗MalfunctionJan 18, 2023Material Deformation; Material Deformation
AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF THE LAD. STENT STRUTS WERE FOUND TO BE DEFECTIVE PRIOR TO PLACEMENT IN PATIENT AT TIME OF STENT PREPARATION. THE STENT WAS SET OFF TO THE SIDE, AND ANOTHER STENT WAS OPENED FOR USE WITHOUT ANY ADVERSE EVENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16194951 ↗
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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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