Orsiro 4.0/26/140Recalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07640130439191), received between Dec 3, 2019 and May 11, 2023 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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
- Device Dislodged or Dislocated4
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 11, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. THE STENT CAME OFF THE BALLOON. IT WAS ASSUMED THAT THE STENT HAD BEEN DISLODGED INSIDE THE LESION, BUT IT COULD NOT BE LOCATED IN PATIENTS BODY. EVENTUALLY, THE DISLODGED STENT WAS DISCOVERED STILL ATTACHED TO THE STYLET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16916144 ↗MalfunctionJan 4, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. WHEN REMOVING THE MANDRIL, THE STENT DISLODGED AND REMAINED ON THE MANDRIL. THE DEVICE WAS NOT USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16096175 ↗MalfunctionSep 9, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT OF A MODERATELY CALCIFIED LESION. PATIENT HAD A PREVIOUS STENT IN THE VEIN GRAFT TO OM. THE ORSIRO STENT COULD NOT PASS THE PROXIMAL EDGE OF THE EXISTING STENT AND DISLODGED FROM THE DELIVERY BALLOON AND WAS ADAPTED TO THE VESSEL WALL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10511669 ↗MalfunctionDec 3, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN TO TREAT A CALCIFIED LESION IN A SVG. DURING WITHDRAWAL, AFTER AN ATTEMPT TO TREAT A LESION IN A SVG TO OM BY DIRECT STENTING, THE STENT DISLODGED. THE STENT COULD BE RETRIEVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9401968 ↗
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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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