Orsiro 2.75/13/140Recalls & 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
- 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 07640130438927), received between Jun 28, 2019 and Jul 19, 2022 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Failure to Advance” (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
- Failure to Advance2
- Device Dislodged or Dislocated1
Patient problems
- No Consequences Or Impact To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 19, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION WITH 75 PERCENT STENOSIS DEGREE IN THE LCX. THERE WAS A PRE-EXISTING LEFT MAIN/LAD STENT THAT COVERS THE OSTIUM OF LCX. WHEN THE ORSIRO STENT WAS ATTEMPTED TO CROSS THE LESION, THE STENT CAME OFF THE BALLOON AND SLID BACK ONTO THE SHAFT OF THE STENT DELIVERY SYSTEM. STENT AND AND DELIVERY SYSTEM WERE REMOVED FROM PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15056596 ↗MalfunctionJul 18, 2019Failure to Advance; Failure to Advance
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN TO TREAT A SEVERELY CALCIFIED LESION (95 PERCENT STENOSIS DEGREE) IN A PROXIMAL TORTUOUS CX. DESPITE SEVERAL PREDILATATIONS THE DEVICE COULD NOT CROSS THE LESION. A 7F GUIDEZILLA EXTENSION CATHETER WAS USED DURING PROCEDURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8802270 ↗MalfunctionJun 28, 2019Failure to Advance; Failure to Advance
THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR USE. DURING LESION CROSSING THE ORSIRO COULD NOT PASS THE CALCIFIED LESION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8746005 ↗
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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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