Orsiro 2.5/26/140Recalls & reported problems
Biotronik AG · Class 3 · Implant
All models of Orsiro (49)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Biotronik Orsiro drug-eluting stent is a small mesh tube placed in a coronary artery to keep it open. The 30 reports mostly describe the stent mesh deforming, coming loose from the balloon or shifting out of position during placement, and failing to cross tight, calcified lesions; two reports mention a coronary artery dissection, and there were no deaths. Most reports describe the problem being noticed without lasting harm to the patient, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 30
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 07640130439153), received between Mar 29, 2019 and Oct 5, 2021 — classified as 2 injuries, 28 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (11 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
- Material Deformation11
- Device Dislodged or Dislocated10
- Failure to Advance7
- Use of Device Problem2
- Fracture1
- Material Rupture1
Patient problems
- No Consequences Or Impact To Patient21
- No Clinical Signs, Symptoms or Conditions7
- Vascular Dissection2
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 5, 2021Material Deformation; Material Deformation
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. A DEFORMATION OF THE DISTAL END OF THE STENT WAS DETECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12579828 ↗MalfunctionMar 29, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. THERE WAS NO STENT ON THE BALLOON. ONLY THE DELIVERY SYSTEM WAS INSIDE THE PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11581906 ↗MalfunctionMar 5, 2021Material Deformation; Material Deformation
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION (75 PERCENT STENOSIS DEGREE) IN THE CX. THE ORSIRO WAS DELIVERED BUT IT GOT CAUGHT AT CX OSTIAL SECTION. AFTER REMOVAL OF THE DEVICE A STENT DEFORMATION WAS OBSERVED. THEREFORE, ANOTHER DES WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11422437 ↗MalfunctionNov 5, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION IN A MODERATELY TORTUOUS RCA. AFTER ATTEMPT TO IMPLANT THE 1ST STENT WHICH COULD NOT CROSS THE LESION (REPORTED SEPARATELY), A 2ND DEVICE WAS DELIVERED, COULD CROSS THE LESION WITH THE DISTAL PART BUT COULD NOT BE INFLATED. IT WAS DETECTED THAT THE STENT DISLODGED. STENT WAS ADAPTED TO THE VESSEL WALL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10790710 ↗MalfunctionOct 29, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT. THE STENT WAS DAMAGED AND CAME OFF THE BALLOON OUTSIDE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10757060 ↗MalfunctionOct 26, 2020Material Deformation; Material Deformation
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION IN A MODERATELY TORTUOUS CX . DURING ATTEMPT TO DELIVER GUIDEPLUS II ST AND THE DEVICE RESISTANCE WAS FELT AND THE DEVICE WAS REMOVED. THE STENT WAS DEFORMED AT THE PROXIMAL END. ANOTHER STENT WAS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10733081 ↗MalfunctionSep 25, 2020Material Deformation; Material Deformation
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. DURING UNPACKING, A STENT DEFORMATION WAS NOTICED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10589677 ↗InjuryAug 25, 2020Use of Device Problem; Use of Device Problem
THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR THE TREATMENT. A CORONARY DISSECTION WAS DETECTED DURING THE PLACEMENT OF THE ORSIRO STENT SYSTEM.
Patient problems: Vascular Dissection
MAUDE report 10449580 ↗InjuryAug 5, 2020Use of Device Problem; Use of Device Problem
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. OSIRO STENT PLACED TO OM1, CULPRIT LESION. SMALL DISSECTION NOTED AFTER. ANOTHER OSIRO STENT PLACED TO DISSECTED AREA DISTAL TO INITIAL STENT, HOWEVER OVERLAPPING. PATIENT IS STABLE.
Patient problems: Vascular Dissection
MAUDE report 10368325 ↗MalfunctionJul 8, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT OF A MILDLY CALCIFIED LESION IN THE LCX. THE DEVICE COULD NOT CROSS THE LESION AND A 6F GUIDELINER WAS INSERTED. UPON RE-INSERTION THE ORSIRO COULD NOT BE DELIVERED TO THE TARGET LESION. IT WAS ATTEMPTED TO REMOVE THE DEVICE BUT THE STENT DISLODGED FROM THE BALLOON. THE STENT WAS CRUSHED AGAINST THE VESSEL WALL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10248465 ↗MalfunctionJun 26, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO DRUG-ELUTING SENT SYSTEM WAS CHOSEN FOR TREATMENT. DURING UNPACKING IT WAS DETECTED THAT THE STENT WAS DISLODGED. THE DEVICE WAS NOT USED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10202687 ↗MalfunctionJun 15, 2020Material Deformation; Material Deformation
THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR USE. WHEN THE STENT PROTECTOR WAS REMOVED FROM THE ORSIRO STENT SYSTEM A STENT DEFORMATION WAS DETECTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10155354 ↗MalfunctionJun 15, 2020Fracture; Fracture
OUS MDR - THE ORSIRO DRUG ELUTING STENT SYSTEM WAS SELECTED FOR USE. THE ORSIRO STENT WAS DELIVERED INTO THE LESION BUT THE DISTAL TIP WAS CAUGHT INSIDE THE CALCIFIED LESION. WHILE APPLYING FORCE THE SHAFT BROKE 20CM FROM THE HUB. THUS THE WHOLE SYSTEM WAS REMOVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10152832 ↗MalfunctionApr 30, 2020Material Deformation; Material Deformation
THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR THE TREATMENT OF A CALCIFIED LESION IN THE LAD. AFTER PRE-DILATATION THE TARGET LESION COULD NOT BE CROSSED AND A STENT DEFORMATION WAS DETECTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10014415 ↗MalfunctionApr 23, 2020Material Deformation; Material Deformation
THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR USE. THE LESION COULD NOT BE CROSSED WITH THE ORSIRO, THEN A GUIDEZILLA II WAS INTRODUCED BUT THE SAME ORSIRO COULD NOT BE ADVANCED THROUGH THE GUIDEZILLA II AND WAS THEREFORE REMOVED. AFTER WITHDRAWAL IT WAS DETECTED THAT THE STENT WAS DEFORMED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9992964 ↗MalfunctionApr 15, 2020Material Deformation; Material Deformation
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT OF A MODERATELY CALCIFIED LESION (100 PERCENT STENOSIS DEGREE) IN THE RCA. AFTER PREPARATION OF THE LESION WITH ROTABLATOR AND PRE-DILATATION THE DEVICE WAS INTRODUCED BUT RESISTANCE WAS FELT. AFTER REMOVAL IT WAS DETECTED THAT THE STENT WAS DEFORMED. ANOTHER STENT WAS USED TO COMPLETE THE INTERVENTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9962345 ↗MalfunctionMar 6, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT OF A LESION (100 PERCENT STENOSIS DEGREE) IN A MODERATELY TORTUOUS LAD. AFTER PRE-DILATATION AND DURING LESION CROSSING THE ORSIRO STENT DISLODGED FROM THE DELIVERY BALLOON. THUS IT WAS CRUSHED AGAINST THE VESSEL WALL BY USING ANOTHER BALLOON.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9800590 ↗MalfunctionFeb 20, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR THE TREATMENT OF A CALCIFIED LESION IN THE LAD. THE ORSIRO WAS DELIVERED THROUGH A GUIDEPLUS BUT THE STENT WAS DEFORMED AND DISPLACED. THE DEVICE WAS REMOVED AND THE INTERVENTION WAS COMPLETED WITH ANOTHER STENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9735128 ↗MalfunctionFeb 20, 2020Failure to Advance; Failure to Advance
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED TO TREAT A SEVERELY CALCIFIED LESION IN THE SEVERELY TORTUOUS LAD AT A BIFURCATION. THE LESION COULD NOT BE CROSSED WITH THE DEVICE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9735094 ↗MalfunctionDec 10, 2019Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated
THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A CALCIFIED LESION IN THE RCA. THE LESION COULD NOT BE CROSSED BY DIRECT STENTING. AFTER REMOVAL OF THE DEVICE IT WAS DETECTED THAT THE STENT WAS DEFORMED AT ITS DISTAL END.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9446218 ↗MalfunctionDec 9, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR USE. AFTER DIRECT STENTING THE ORSIRO COULD NOT PASS A PREVIOUSLY IMPLANTED STENT AND WAS THEREFORE WITHDRAWN. DILATATION OF THE LESION WAS PERFORMED, DEVICE WAS RE-INSERTED BUT COULD NOT CROSS AGAIN. UPON REMOVAL THE STENT DISLODGED FROM THE BALLOON. EVENTUALLY THE DISLODGED ORSIRO STENT WAS REMOVED BY USING A LASSO.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9440918 ↗MalfunctionOct 23, 2019Failure to Advance; Material Deformation; Failure to Advance; Material Deformation
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN TO TREAT A CALCIFIED LESION (75 PERCENT STENOSIS DEGREE) IN THE LCX. AFTER PRE-DILATATION THE ORSIRO COULD NOT CROSS THE LESION. THEREFORE THE ORSIRO WAS REMOVED AND A STENT DEFORMATION WAS NOTICED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9224420 ↗MalfunctionOct 8, 2019Material Rupture; Material Rupture
AN ORSIRO DRUG-ELUTING STENT WAS CHOSEN TO TREAT A CALCIFIED LESION IN THE PROXIMAL CX. DURING INFLATION THE BALLOON RUPTURED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9167845 ↗MalfunctionJul 1, 2019Failure to Advance; Failure to Advance
THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR USE. A FAILURE OF IMPLANTATION WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8751223 ↗MalfunctionJun 26, 2019Failure to Advance; Failure to Advance
THE ORSIRO DRUG-ELUTING STENT SYSTEM COULD NOT PASS THE LESION. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8737386 ↗
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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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