Orsiro 3.0/13/140Recalls & 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
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07640130438934), received between May 9, 2019 and Jul 7, 2021 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Failure to Advance” (6 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
- Failure to Advance6
- Device Dislodged or Dislocated4
Patient problems
- No Consequences Or Impact To Patient9
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 7, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. AFTER PULLING THE STENT CATHETER FROM THE TRANSPORTATION RING IT WAS NOTICED THAT THE STENT WAS NOT ON THE BALLOON. THE ORSIRO WAS DISCARDED AND ANOTHER STENT WAS USED. THIS ALL HAPPENED OUTSIDE OF THE BODY AND THE ORSIRO NEVER ENTERED THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12127087 ↗MalfunctionJun 30, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION IN A SEVERELY TORTUOUS LM TO CX. AFTER PRE-DILATATION THE TARGET LESION COULD NOT BE CROSSED. THE ORSIRO WAS REMOVED, A GUIDELINER WAS ADDED AND ANOTHER PRE-DILATATION WAS CONDUCTED BUT THE TARGET LESION COULD NOT BE CROSSED AGAIN. UPON REMOVAL IT WAS NOTICED THAT THE STENT WAS DISLODGED FROM BALLOON.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10214933 ↗MalfunctionFeb 25, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT. IT WAS DETECTED THAT NO STENT WAS ON THE BALLOON. THE DEVICE WAS NOT USED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9751236 ↗MalfunctionAug 21, 2019Failure to Advance; Failure to Advance
THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR USE. AFTER PRE-DILATATION THE TARGET LESION COULD NOT BE CROSSED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8915692 ↗MalfunctionJul 30, 2019Failure to Advance; Failure to Advance
AFTER PRE-DILATATION THE ORSIRO DRUG-ELUTING STENT SYSTEM COULD NOT PASS THE TORTUOUS AND CALCIFIED LESION IN THE LAD.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8841943 ↗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 8714358 ↗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 8712245 ↗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 8712193 ↗MalfunctionJun 14, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO DRUG-ELUTING STENT WAS CHOSEN FOR TREATMENT. DURING UNPACKING, THE STENT WAS STUCK IN THE STENT PROTECTOR AND FELL OFF TABLE WHEN TRYING TO GET IT UNSTUCK.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8701350 ↗MalfunctionMay 9, 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 PRE-DILATATION OR LESION DETAILS WERE PROVIDED YET.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8597379 ↗
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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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