Orsiro 2.5/15/140Recalls & 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
- 15
- Deaths reported
- 1
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 07640130438972), received between Apr 15, 2019 and May 11, 2021 — classified as 1 death, 2 injuries, 12 malfunctions.
The most frequently reported specific device problem is “Failure to Advance” (8 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 Advance8
- Device Dislodged or Dislocated2
- Material Deformation2
- Patient Device Interaction Problem2
- Entrapment of Device1
- Inflation Problem1
Patient problems
- No Consequences Or Impact To Patient9
- No Clinical Signs, Symptoms or Conditions2
- Angina1
- Death1
- No Known Impact Or Consequence To Patient1
- Vascular Dissection1
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 11, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN THE SEVERELY TORTUOUS MID CX. STENT WOULD NOT CROSS LESION AND AFTER REMOVAL IT WAS NOTICED THAT THE STENT WAS DAMAGED. MULTIPLE STENTS WERE ATTEMPT TO BE INSERTED BUT NOTHING WAS ABLE TO CROSS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11806271 ↗InjuryMar 31, 2021Patient Device Interaction Problem; Patient Device Interaction Problem
AN ORSIRO DRUG-ELUTING STENT WAS IMPLANTED IN CONTEXT OF THE BIOFLOW-VII STUDY. PATIENT EXPERIENCED CHEST PAIN. THE RAMUS STENT WAS FOUND TO BE 80 PERCENT STENOSED AT THE DISTAL PORTION.
Patient problems: Angina
MAUDE report 11595546 ↗InjuryJan 14, 2021Patient Device Interaction Problem; Patient Device Interaction Problem
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. A DISTAL EDGE DISSECTION WAS NOTED AFTER PLACING THE STENT. THIS WAS TREATED WITH AN ADDITIONAL STENT DURING THE INDEX PROCEDURE.
Patient problems: Vascular Dissection
MAUDE report 11174469 ↗MalfunctionOct 30, 2020Material Deformation; Material Deformation
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. PRIOR TO USE IT WAS DETECTED THAT THE STENT WAS DEFORMED. A STRUT WAS STICKING OUT. THE DEVICE WAS NOT USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10764380 ↗MalfunctionJul 31, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION. THE DEVICE COULD NOT CROSS THE LESION AND WAS WITHDRAWN. THEN IT WAS DETECTED THAT THE STENT WAS DISLODGED. IT GOT CAUGHT IN THE COPILOT VALVE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10353477 ↗DeathJan 28, 2020Inflation Problem; Inflation Problem
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED TO TREAT A SEVERELY CALCIFIED LESION (100 PERCENT STENOSIS DEGREE) IN A MILDLY TORTUOUS LAD. AFTER PRE-DILATATION THE DEVICE WAS PLACED IN THE TARGET LESION BUT COULD NOT BE FULLY INFLATED. AFTER WITHDRAWAL, THE STENT WAS STILL ON THE BALLOON. PATIENT FINALLY PASSED AWAY. ACCORDING TO THE INFORMATION FROM THE HOSPITAL PATIENT WAS A STEMI. THE DEATH WAS REPORTED AS NOT DEVICE RELATED.
Patient problems: Death
MAUDE report 9639208 ↗MalfunctionSep 4, 2019Entrapment of Device; Entrapment of Device
THE ORSIRO DRUG ELUTING STENT SYSTEM WAS SELECTED FOR USE. AFTER PREDILATATION OF THE CALCIFIED AND TORTUOUS LESION IN THE PROXIMAL RCA THE ORSIRO COULD NOT CROSS AND WAS THEREFORE WITHDRAWN. DURING WITHDRAWAL THE STENT GOT CAUGHT AND DISLODGED FROM THE DELIVERY SYSTEM. IT WAS TRIED TO RETRIEVE THE STENT BY USING A SNARE BUT THE ATTEMPT WAS UNSUCCESSFUL AND EVENTUALLY THE STENT REMAINED INSIDE THE PATIENTS BODY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8962516 ↗MalfunctionSep 3, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE ORSIRO DRUG ELUTING STENT SYSTEM WAS SELECTED FOR USE. THE STENT COULD NOT PASS THE CALCIFIED AND TORTUOUS LESION AND DISLODGED FROM THE BALLOON.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8958340 ↗MalfunctionAug 15, 2019Failure to Advance; Failure to Advance
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR THE TREATMENT OF A CALCIFIED AND TORTUOUS LESION AFTER PRE-DILATATION. THE TARGET LESION COULD NOT BE CROSSED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8897350 ↗MalfunctionJul 23, 2019Failure to Advance; Failure to Advance
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT. DESPITE SEVERAL ATTEMPTS THE DEVICE COULD NOT CROSS THE PRE-DILATED LESION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8819106 ↗MalfunctionJun 28, 2019Failure to Advance; Failure to Advance
THE ORSIRO DRUG-ELUTING STENT SYSTEM COULD NOT PASS THE CALCIFIED LESION. NO MORE INFORMATION AVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8746026 ↗MalfunctionJun 26, 2019Failure to Advance; Failure to Advance
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN TO TREAT A SEVERELY CALCIFIED LESION (90% STENOSIS DEGREE) IN A CX. THE DEVICE COULD NOT PASS THE LESION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8734363 ↗MalfunctionJun 19, 2019Failure to Advance; Failure to Advance
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT OF A LAD. THE DEVICE WAS UNABLE TO CROSS THE LESION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8714355 ↗MalfunctionJun 19, 2019Failure to Advance; Failure to Advance
THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR USE. AFTER PRE-DILATATION IT WAS ATTEMPTED TO PLACE THE ORSIRO AT A DISSECTION BUT THE STENT COULD NOT PASS THE CALCIFIED LESION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8712232 ↗MalfunctionApr 15, 2019Failure to Advance; Failure to Advance
THE ORSIRO DRUG-ELUTING STENT SYSTEM COULD NOT PASS THE SEVERELY CALCIFIED AND TORTUOUS LESION IN THE PROXIMAL LCX.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8516660 ↗
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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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