Orsiro 4.0/40/140Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07640130439467), received between May 8, 2019 and Feb 3, 2020 — classified as 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 16, 2026.
Most reported problems
Device problems
- Device Dislodged or Dislocated1
- Failure to Advance1
- Material Deformation1
Patient problems
- No Consequences Or Impact To Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 3, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT OF A LESION IN THE RCA. THE STENT DISLODGED INSIDE GUIDING CATHETER. THE STENT WAS RETRIEVED WITH ANOTHER BALLOON.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9662566 ↗MalfunctionJun 28, 2019Material Deformation; Material Deformation
THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR USE. DURING LESION CROSSING A STENT DEFORMATION WAS NOTICED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8746011 ↗MalfunctionMay 8, 2019Failure to Advance; Failure to Advance
AFTER PRE-DILATATION THE ORSIRO COULD NOT PASS THE SEVERELY CALCIFIED LESION IN THE MEDIAL RCA.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8590945 ↗
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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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