Orsiro 2.5/13/140Recalls & reported problems
Biotronik AG · Class 3 · Implant
All models of Orsiro (49)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07640130438910), received between Apr 25, 2019 and Dec 21, 2020 — classified as 1 injury, 8 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 16, 2026.
Most reported problems
Device problems
- Device Dislodged or Dislocated3
- Failure to Advance3
- Difficult to Remove1
- Material Deformation1
- Patient Device Interaction Problem1
Patient problems
- No Consequences Or Impact To Patient6
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
InjuryDec 21, 2020Patient Device Interaction Problem; Patient Device Interaction Problem
BIOFLOW VII: AFTER SUCCESSFUL ORSIRO STENT IMPLANTATION PATIENT EXPERIENCED SOME PERSISTENT OOZING FROM THE RIGHT RADIAL SITE. PATIENT STAYED OVERNIGHT FOR OBSERVATIONS ON RIGHT RADIAL ACCESS SITE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11052752 ↗MalfunctionOct 29, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. THE LESION COULD NOT BE CROSSED AND THE DEVICE WAS REMOVED. WHEN THE DEVICE WAS READY TO LOAD AGAIN IT WAS DISCOVERED THAT THERE WAS NO STENT ON THE BALLOON. THE STENT WAS FOUND IN THE CO-PILOT HEMOSTATIC VALVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10759566 ↗MalfunctionFeb 4, 2020Material Deformation; Material Deformation
AN ORSIRO WAS SELECTED FOR TREATMENT. BEFORE INTRODUCING INTO PATIENT, IT WAS NOTICED THAT THE STENT WAS DEFORMED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9667185 ↗MalfunctionDec 2, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN TO TREAT A PRE-DILATED LESION IN THE OM. THE ORSIRO WAS UNABLE TO CROSS A PREVIOUS IMPLANTED STENT. AFTER REMOVAL PRIOR TO RE-INSERTION IT WAS DETECTED THAT THE STENT WAS DISLODGED INSIDE PATIENT. THE STENT WAS ADAPTED TO THE VESSEL WALL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9397781 ↗MalfunctionSep 17, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT. DURING UNPACKING THE STENT DISLODGED FROM DELIVERY SYSTEM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9077732 ↗MalfunctionAug 26, 2019Difficult to Remove; Difficult to Remove
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT OF A STENOSIS (80 PERCENT STENOSIS DEGREE) IN A TORTUOUS PART OF THE LAD. AFTER PRE-DILATATION THE STENT WAS SUCCESSFULLY DEPLOYED. DURING REMOVAL OF THE DEVICE RESISTANCE WAS NOTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8932819 ↗MalfunctionJun 19, 2019Failure to Advance; Failure to Advance
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT. THE DEVICE WAS UNABLE TO CROSS THE LESION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8712213 ↗MalfunctionMay 16, 2019Failure to Advance; Failure to Advance
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED TO TREAT A CORONARY LESION, BUT COULD NOT CROSS. NO DETAILS ABOUT LESION DETAILS WERE PROVIDED YET.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8617822 ↗MalfunctionApr 25, 2019Failure to Advance; Failure to Advance
THE ORSIRO DRUG-ELUTING STENT SYSTEM COULD NOT PASS TWO PREVIOUSLY IMPLANTED STENTS IN THE SEVERELY TORTUOUS AND CALCIFIED LESION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8552471 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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