Orsiro MissionRecalls & reported problems across all models
Biotronik AG · 49 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 313
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls
- 0
We found 49 models of Orsiro Mission by Biotronik AG in the FDA's device registry (GUDID). Together they are named in 313 adverse event reports in the FDA's MAUDE database, received between Nov 2, 2021 and Sep 29, 2026 — classified as 8 injuries, 305 malfunctions.
The most frequently reported specific device problem is “Failure to Advance” (211 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Orsiro Mission problems
Device problems
- Failure to Advance211
- Device Dislodged or Dislocated73
- Material Deformation33
- Inflation Problem5
- Use of Device Problem5
- Fracture4
- Patient Device Interaction Problem3
- Fluid/Blood Leak2
Patient problems
- No Clinical Signs, Symptoms or Conditions301
- Chest Pain4
- Thrombosis/Thrombus3
- Foreign Body In Patient2
- Asystole1
- Failure of Implant1
- Insufficient Information1
- Low Blood Pressure/ Hypotension1
Orsiro Mission models
49 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Orsiro Mission 2.25/13/140Coronary drug-eluting stent13 reports
- Orsiro Mission 2.5/22/140Coronary drug-eluting stent13 reports
- Orsiro Mission 2.5/40/140Coronary drug-eluting stent13 reports
- Orsiro Mission 3.5/22/140Coronary drug-eluting stent12 reports
- Orsiro Mission 3/30/140Coronary drug-eluting stent12 reports
- Orsiro Mission 2.25/9/140Coronary drug-eluting stent11 reports
- Orsiro Mission 2.5/15/140Coronary drug-eluting stent11 reports
- Orsiro Mission 3.5/18/140Coronary drug-eluting stent11 reports
- Orsiro Mission 3/22/140Coronary drug-eluting stent11 reports
- Orsiro Mission 3.0/35/140Coronary drug-eluting stent11 reports
- Orsiro Mission 3/15/140Coronary drug-eluting stent10 reports
- Orsiro Mission 3/9/140Coronary drug-eluting stent9 reports
- Orsiro Mission 2.25/18/140Coronary drug-eluting stent9 reports
- Orsiro Mission 3/13/140Coronary drug-eluting stent8 reports
- Orsiro Mission 3.5/15/140Coronary drug-eluting stent8 reports
- Orsiro Mission 2.5/26/140Coronary drug-eluting stent8 reports
- Orsiro Mission 2.5/30/140Coronary drug-eluting stent8 reports
- Orsiro Mission 2.5/35/140Coronary drug-eluting stent8 reports
- Orsiro Mission 2.5/13/140Coronary drug-eluting stent7 reports
- Orsiro Mission 2.25/15/140Coronary drug-eluting stent7 reports
- Orsiro Mission 3/26/140Coronary drug-eluting stent7 reports
- Orsiro Mission 3.5/35/140Coronary drug-eluting stent7 reports
- Orsiro Mission 2.25/22/140Coronary drug-eluting stent6 reports
- Orsiro Mission 2.75/26/140Coronary drug-eluting stent6 reports
- Orsiro Mission 2.25/30/140Coronary drug-eluting stent6 reports
- Orsiro Mission 3.5/40/140Coronary drug-eluting stent6 reports
- Orsiro Mission 3.5/9/140Coronary drug-eluting stent5 reports
- Orsiro Mission 4/15/140Coronary drug-eluting stent5 reports
- Orsiro Mission 2.5/18/140Coronary drug-eluting stent5 reports
- Orsiro Mission 4/26/140Coronary drug-eluting stent5 reports
- Orsiro Mission 2.75/30/140Coronary drug-eluting stent5 reports
- Orsiro Mission 2.75/18/140Coronary drug-eluting stent4 reports
- Orsiro Mission 3/18/140Coronary drug-eluting stent4 reports
- Orsiro Mission 2.25/26/140Coronary drug-eluting stent4 reports
- Orsiro Mission 3.5/26/140Coronary drug-eluting stent4 reports
- Orsiro Mission 3/40/140Coronary drug-eluting stent4 reports
- Orsiro Mission 2.5/9/140Coronary drug-eluting stent3 reports
- Orsiro Mission 2.75/15/140Coronary drug-eluting stent3 reports
- Orsiro Mission 2.75/22/140Coronary drug-eluting stent3 reports
- Orsiro Mission 4/22/140Coronary drug-eluting stent3 reports
- Orsiro Mission 2.75/40/140Coronary drug-eluting stent3 reports
- Orsiro Mission 4/40/140Coronary drug-eluting stent3 reports
- Orsiro Mission 2.75/13/140Coronary drug-eluting stent2 reports
- Orsiro Mission 3.5/13/140Coronary drug-eluting stent2 reports
- Orsiro Mission 4/13/140Coronary drug-eluting stent2 reports
- Orsiro Mission 4/18/140Coronary drug-eluting stent2 reports
- Orsiro Mission 2.75/35/140Coronary drug-eluting stent2 reports
- Orsiro Mission 4/9/140Coronary drug-eluting stent1 report
- Orsiro Mission 3.5/30/140Coronary drug-eluting stent1 report
Recent Orsiro Mission adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Failure to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927970 ↗MalfunctionSep 16, 2026Failure to Advance
The Orsiro Mission drug-eluting stent system was selected for treatment of a mildly calcified lesion in a moderate tortuous segment of the OM. After pre-dilatation, the device was introduced into the patient's body but could not pass the lesion. A shorter stent was used successfully to finish the procedure.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50782790 ↗InjuryAug 28, 2026Fracture; Material Deformation; Unintended Movement
The Orsiro Mission drug-eluting stent system was selected for treatment of a mildly calcified lesion (65% stenosis degree) in a mildly tortuous segment of the proximal RCA. During the advancement to the target lesion, resistance was met, resulting in bending and deformation of the stent struts. The device was not deployed. Subsequently, the patient moved their arm, which led to dislodgement of the guiding catheter, guidewire, and stent into the aorta. An attempt was made to retrieve all devices through the radial sheath; however, the stent together with the distal tip could not be withdrawn. A radial artery cutdown procedure was subsequently required to remove the remaining part.
Patient problems: Foreign Body In Patient
MAUDE report 50494942 ↗MalfunctionJul 22, 2026Failure to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25904402 ↗MalfunctionJul 22, 2026Failure to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25904400 ↗MalfunctionJul 22, 2026Failure to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25904112 ↗MalfunctionJul 22, 2026Failure to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25904097 ↗MalfunctionJul 22, 2026Failure to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25904079 ↗MalfunctionJul 21, 2026Failure to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25885277 ↗MalfunctionJul 21, 2026Failure to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25885276 ↗MalfunctionJul 21, 2026Failure to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25885275 ↗MalfunctionJul 10, 2026Failure to Advance
THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION IN THE MID LAD. THE AFFECTED DEVICE WAS INTRODUCED INTO THE PATIENT'S BODY BUT WAS UNABLE TO CROSS THE LESION. 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 25778132 ↗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 ↗MalfunctionJul 7, 2026Device Dislodged or Dislocated
THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A CALCIFIED LESION IN A TORTUOUS SEGMENT OF THE BIFURCATION LCX/OM1 WHERE A PREVIOUSLY IMPLANTED STENT WAS PRESENT. PRE-DILATION WAS PERFORMED USING A 2.0/12 MINI TREK BALLOON. THE AFFECTED DEVICE WAS INTRODUCED INTO THE PATIENT'S BODY AND ADVANCED TOWARDS THE TARGET LESION, BUT GOT CAUGHT AT THE PREVIOUSLY IMPLANTED STENT. AS A RESULT, THE STENT WAS STRIPPED OFF THE BALLOON. THE PHYSICIAN WAS ABLE TO SECURE THE STENT TO THE VESSEL WALL AT THE SITE WHERE IT HAD BECOME DISLODGED USING A 2.5/10 MEDTRONIC EUPHORA BALLOON. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25729859 ↗MalfunctionJul 7, 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 SEGMENT OF THE MEDIAL LCX. 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25729857 ↗
Other Biotronik AG products
All Biotronik AG devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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