Orsiro 3.0/30/140Recalls & 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
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07640130439238), received between Apr 9, 2019 and Oct 19, 2020 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Failure to Advance” (3 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 Advance3
- Device Dislodged or Dislocated2
- Difficult to Remove1
- Material Rupture1
Patient problems
- No Consequences Or Impact To Patient6
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 19, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TORTUOUS LAD. AFTER IMPLANTING ONE STENT AN ATTEMPT WAS MADE TO DELIVER A 2ND STENT PROXMIAL TO THE FIRST, BUT A LOT OF RESISTANCE WAS FELT. WHILE PULLING BACK THE DEVICE THE STENT DISLODGED IN THE GUIDING CATHETER. THE STENT WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10701640 ↗MalfunctionJun 3, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. THE STENT DISLODGED DURING PREPARATION. IT WAS INITIALLY NOT NOTICED AND THE DEVICE WAS INTRODUCED INTO PATIENT. THE DISLODGEMENT WAS DETECTED DURING INFLATION OF THE BALLOON. THE STENT WAS FOUND ON THE TABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10115841 ↗MalfunctionAug 26, 2019Difficult to Remove; Difficult to Remove
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT OF A STENOSIS (100 PERCENT STENOSIS DEGREE) IN A TORTUOUS PART OF THE PROXIMAL LAD. AFTER PREDILATATION THE STENT WAS SUCCESSFULLY DEPLOYED. DURING REMOVAL OF THE DEVICE RESISTANCE WAS NOTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8932821 ↗MalfunctionJul 29, 2019Failure to Advance; Failure to Advance
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN TO TREAT A CALCIFIED LESION (70 PERCENT STENOSIS DEGREE) IN A TORTUOUS VESSEL. DESPITE PRE-DILATATION IT WAS NOT POSSIBLE TO CROSS THE LESION WITH THE DEVICE AS USUAL. A BODY WIRE WAS ADDITIONALLY USED TO ADVANCE THE SYSTEM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8837964 ↗MalfunctionJun 19, 2019Failure to Advance; Failure to Advance
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN TO TREAT A PRE-DILATED LESION IN A PROXIMAL LAD. THE DEVICE WAS UNABLE TO CROSS THE LESION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8712254 ↗MalfunctionJun 19, 2019Failure to Advance; Failure to Advance
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN TO TREAT A PRE-DILATED CALCIFIED LESION (100% STENOSIS DEGREE) IN A MID CX. THE DEVICE WAS UNABLE TO CROSS THE LESION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8712228 ↗MalfunctionApr 9, 2019Material Rupture; Material Rupture
OUS MDR - AN ORSIRO DRUG ELUTING STENT SYSTEM WAS SELECTED FOR USE. IT WAS REPORTED THAT DURING INFLATION THE BALLOON OF THE STENT SYSTEM RUPTURED AT 10 BAR. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8497831 ↗
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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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