Orsiro 2.75/30/140Recalls & 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 07640130439221), received between Jul 23, 2019 and Aug 3, 2021 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (2 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
- Material Deformation2
- Failure to Advance1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 3, 2021Material Deformation; Material Deformation
AN ORSIRO DRUG ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A PRE-DILATED LESION IN THE MID LAD. STENT STRUT WAS RAISED AND IT WAS NOT POSSIBLE TO DEPLOY THE STENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12271345 ↗MalfunctionMar 3, 2021Material Deformation; Material Deformation
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. A STENT DEFORMATION WAS NOTICED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11404407 ↗MalfunctionJul 23, 2019Failure to Advance; Failure to Advance
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN TO TREAT A SEVERELY CALCIFIED LESION. DESPITE SEVERAL ATTEMPTS THE DEVICE COULD NOT CROSS THE PRE-DILATED LESION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8819690 ↗
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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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