Orsiro 2.5/30/140Recalls & 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
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07640130439214), received between Jun 19, 2019 and Oct 27, 2022 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated3
- Adverse Event Without Identified Device or Use Problem1
- Difficult to Remove1
- Failure to Advance1
- Material Deformation1
- Material Rupture1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Consequences Or Impact To Patient4
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. STENT CAME OFF THE WIRE WITH THE REMOVAL OF THE STENT PROTECTIVE COVER BEFORE INSERTION. THE STENT FELL OUTSIDE OF THE STERILE FIELD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15679508 ↗MalfunctionOct 14, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. DURING PREPARATION IT WAS DETECTED THAT NO STENT WAS ON THE BALLOON. ANOTHER DEVICE WAS USED TO COMPLETE THE INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12631219 ↗MalfunctionSep 8, 2021Material Deformation; Material Deformation
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. WHEN LOADING THE DEVICE ONTO THE GUIDE WIRE, IT WAS NOTICED THAT THE STENT WAS DEFORMED AT THE DISTAL END. A STENT STRUT WAS STICKING OUT. THE DEVICE WAS NOT USED. ANOTHER ORSIRO WITH SAME SIZE WAS USED TO COMPLETE THE INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12438709 ↗MalfunctionJan 21, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. AN ATTEMPT WAS MADE TO TREAT THE LAD THROUGH THE LIMA. THE LIMA WAS EXTREMELY TORTUOUS. THE STENT WAS STUCK AND DID NOT ADVANCE AND NEVER MADE IT PAST THE LIMA TO THE LESION. WHEN THE STENT WAS PULLED OUT IT WAS NOTICED THAT THE PROXIMAL PORTION OF THE STENT WAS DEFORMED AND DISLOCATED PROXIMAL FROM THE BALLOON. ANOTHER STENT WAS USED TO COMPLETE THE INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11208424 ↗MalfunctionDec 19, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR USE. THE SEVERE CALCIFIED, PRE-DILATED LESION COULD NOT BE CROSSED WITH THE DEVICE AND IT WAS REMOVED. WHEN ATTEMPTING TO RE-INSERT THE STENT SYSTEM IT WAS NOTICED THAT NO STENT WAS ON THE BALLOON.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9497604 ↗MalfunctionOct 30, 2019Difficult to Remove; Difficult to Remove
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT OF A STENOSIS IN THE MID LAD . THE STENT WAS SUCCESSFULLY DEPLOYED. DURING REMOVAL OF THE DEVICE RESISTANCE WAS NOTED AND THE USED GUIDING CATHETER HAS SHIFTED TO THE LEFT MAIN ARTERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9257895 ↗MalfunctionJul 23, 2019Material Rupture; Material Rupture
THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR USE. NO PRE-DILATATION WAS CONDUCTED. DURING INFLATION THE BALLOON OF THE ORSIRO STENT SYSTEM RUPTURED LONGITUDINAL AT 16 TO 18 BAR. THE STENT REMAINED DEPLOYED INSIDE THE PATIENTS BODY AND THE DELIVERY SYSTEM WAS REMOVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8819687 ↗MalfunctionJun 19, 2019Failure to Advance; Failure to Advance
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT. THE DEVICE WAS UNABLE TO CROSS THE LESION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8712253 ↗
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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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