Orsiro 3.0/9/140Recalls & 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
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07640130438873), received between Jun 19, 2019 and Feb 19, 2021 — classified as 8 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 Dislocated1
- Fracture1
Patient problems
- No Consequences Or Impact To Patient7
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 19, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. IT WAS REPORTED THAT DURING UNPACKING THE STENT CAME OFF OF THE BALLOON AND WAS LOCATED WITHIN THE PROTECTIVE COVER THAT WAS REMOVED AT THE SAME TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11350991 ↗MalfunctionFeb 21, 2020Fracture; Fracture
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT. THE LESION COULD NOT BE CROSSED WITH THE DEVICE. AFTER WITHDRAWAL IT WAS NOTICED THAT THE STENT SEEMED TO BE FRACTURED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9741715 ↗MalfunctionFeb 21, 2020Failure to Advance; Failure to Advance
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT. THE LESION COULD NOT BE CROSSED WITH THE DEVICE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9741713 ↗MalfunctionSep 19, 2019Failure to Advance; Failure to Advance
THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR THE TREATMENT OF A SEVERELY CALCIFIED LESION. DURING LESION CROSSING THE TARGET LESION COULD NOT BE CROSSED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9087168 ↗MalfunctionAug 13, 2019Failure to Advance; Failure to Advance
THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED TO TREAT A SEVERELY CALCIFIED LESION IN THE DISTAL RCA. TWO WIRES AS WELL AS A GUIDELINER WERE USED AS SUPPORT TO CROSS THE TARGET LESION BUT IT COULD NOT BE CROSSED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8888691 ↗MalfunctionJul 1, 2019Failure to Advance; Failure to Advance
THE ORSIRO DRUG-ELUTING STENT SYSTEM COULD NOT PASS THE SEVERELY CALCIFIED LESION IN THE LAD.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8750649 ↗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 8712184 ↗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 8712179 ↗
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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 13, 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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