Orsiro 3.0/26/140Recalls & reported problems
Biotronik AG · Class 3 · Implant
All models of Orsiro (49)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Biotronik Orsiro drug-eluting stent is a small mesh tube placed in a narrowed coronary artery to hold it open. The 37 reports mostly describe the stent deforming or shifting position, and failing to pass through tight, calcified or twisty vessels, so doctors pulled it back out and used a different stent; one report mentions fracture and one rupture. No deaths or injuries are reported. No recalls name this device, and no reports were filed in the past year.
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
- 37
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 07640130439177), received between Apr 3, 2019 and Jul 19, 2022 — classified as 37 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (16 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 18, 2026.
Most reported problems
Device problems
- Device Dislodged or Dislocated16
- Material Deformation14
- Failure to Advance8
- Fracture1
- Material Rupture1
Patient problems
- No Clinical Signs, Symptoms or Conditions18
- No Consequences Or Impact To Patient18
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 19, 2022Failure to Advance; Failure to Advance
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF THE RCA THE ORSIRO COULD NOT PASS THE LESION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15059265 ↗MalfunctionApr 11, 2022Material Deformation; Material Deformation
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION WITH 90 PERCENT STENOSIS DEGREE IN THE LAD. RESISTANCE WAS FELT AS IT WAS ATTEMPTED TO PUSH THE STENT THROUGH THE GUIDING CATHETER. THE SYSTEM WAS REMOVED FROM THE PATIENTS BODY AND A DEFORMATION OF THE STENT WAS DETECTED. ANOTHER DEVICE WAS USED TO COMPLETE THE INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14074386 ↗MalfunctionJan 11, 2022Material Deformation; Material Deformation
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFED LESION (95 PERCENT STENOSIS DEGREE) IN THE MODERATELY TORTUOUS PROXIMAL LCX. AFTER PRE-DILATATION, THE ORSIRO STENT BECAME DEFORMED DURING THE ATTEMPT TO CROSS THE LESION. THUS, ANOTHER STENT WAS USED TO FINISH THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13226102 ↗MalfunctionJan 5, 2022Failure to Advance; Failure to Advance
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (85 PERCENT STENOSIS DEGREE) IN THE MODERATELY TORTUOUS MID RCA. THE LESION COULD NOT BE CROSSED WITH THE DEVICE. THE DEVICE WAS WITHDRAWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13168341 ↗MalfunctionJan 5, 2022Failure to Advance; Failure to Advance
AN ORSIRO DRUG ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (85 PERCENT STENOSIS DEGREE) IN THE MIDDLE OF A MODERATELY TORTUOUS UNKNOWN VESSEL. THE LESION COULD NOT BE CROSSED WITH THE DEVICE. THE DEVICE WAS WITHDRAWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13167963 ↗MalfunctionOct 29, 2021Material Deformation; Material Deformation
AN ORSIRO DRUG ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF THE MODERATE CALCIFIED LESION IN A MODERATE TORTUOUS RCA. DESPITE PRE-DILATATION THE LESION COULD NOT BE CROSSED WITH THE DEVICE DUE TO VESSEL TORTUOSITY. THE STENT WAS DEFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12721031 ↗MalfunctionOct 14, 2021Material Deformation; Material Deformation
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN A MILDLY TORTUOUS MID LAD. AFTER STENTING AND POST-DILATATION OF THE DISTAL STENT SEGMENT A DEFORMATION OF THE PROXIMAL STENT WAS NOTICED. THE STENT SEEMED MILDLY SHORTENED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12631744 ↗MalfunctionOct 14, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A PRE-DILATED LESION (99 PERCENT STENOSIS DEGREE) IN THE MID LAD. DURING ATTEMPT TO DELIVER THE STENT TO THE TARGET LESION, SOME RESISTANCE WAS FELT. WHEN APPLYING MORE FORCE THE DEVICE PASSED, BUT THE STENT DISLODGED. THE STENT WAS RETRIEVED WITH A SNARE. ANOTHER STENT WAS USED TO COMPLETE THE INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12631743 ↗MalfunctionOct 7, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF THE LCX. WHILE REMOVING THE STENT PROTECTOR THE STENT WAS NOT ON THE BALLOON. THE STENT PROTECTOR WAS SHAKEN, AND THEN THE STENT WAS DROPPED. THE DEVICE WAS NOT USED. ANOTHER ORSIRO WAS USED TO COMPLETE THE INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12589431 ↗MalfunctionOct 5, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. THE DEVICE COULD NOT PASS THE LESION. THE STENT WAS DEFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12579840 ↗MalfunctionSep 15, 2021Failure to Advance; Failure to Advance
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (85 PERCENT STENOSIS DEGREE) IN A MODERATELY TORTUOUS VESSEL. THE STENT COULD NOT BE DELIVERED THROUGH THE LESION. THE DEVICE WAS REMOVED FROM PATIENTS BODY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12474094 ↗MalfunctionSep 9, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A PRE-DILATED MILDLY CALCIFIED LESION (80 PERCENT STENOSIS DEGREE) IN THE MODERATELY TORTUOUS MID LCX. DURING DELIVERY, THE DEVICE GOT CAUGHT ON THE PROXIMAL END OF THE GUIDEZILLA EXTENSION CATHETER AND WAS DISLODGED OFF THE DELIVERY SYSTEM. THE STENT WAS RETRIEVED WITH A BALLOON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12445588 ↗MalfunctionAug 19, 2021Material Deformation; Material Deformation
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION IN THE LAD. USING AN EXTENSION CATHETER, THE ORSIRO REACHED THE LESION. DURING INFLATION RESISTANCE WAS FELT. DILATION WAS PERFORMED 3 TIMES AND THE DELIVERY CATHETER WAS REMOVED FROM THE BODY. HOWEVER, IT WAS CONFIRMED THAT THE STENT CAME OUT OF PATIENTS BODY WITHOUT BEING EXPANDED AND THE STENT EDGE BEING DEFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12342381 ↗MalfunctionJul 14, 2021Material Deformation; Material Deformation
AN ORSIRO DRUG ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A CALCIFIED LESION IN THE PROXIMAL RCA. WHILE THREADING THE DEVICE ONTO THE GUIDE WIRE IT WAS NOTICED THAT THE STENT WAS DEFORMED. THE DEVICE WAS NOT USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12166358 ↗MalfunctionJul 1, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION (95 PERCENT STENOSIS DEGREE) IN THE LAD. DURING UNPACKING IT WAS NOTICED THAT THE STENT WAS NOT ON THE BALLOON ANYMORE. ANOTHER DEVICE WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12099146 ↗MalfunctionJan 12, 2021Material Deformation; Material Deformation
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A CALCIFIED LESION (80 PERCENT STENOSIS DEGREE) IN A MILDLY TORTUOUS RCA. THE LESION COULD NOT BE CROSSED WITH THE DEVICE. THE STENT WAS DEFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11156674 ↗MalfunctionDec 8, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION IN A MODERATELY TORTUOUS RCA. AFTER PRE-DILATATION A GUIDE EXTENSION WAS INSERTED FIRST. THEN, THE ORSIRO WAS ATTEMPTED TO BE INSERTED BUT IT WAS CAUGHT OSTIAL OF THE EXTENSION AND COULD NOT PUSHED OUT. THEREFORE, THE DEVICE WAS ATTEMPTED TO BE REMOVED BUT THE STENT WAS DISLODGED ON THE WIRE. USING A SMALL BALLOON CATHETER, THE STENT WAS REMOVED. ANOTHER ORSIRO WAS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10970106 ↗MalfunctionDec 1, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. AFTER THE REMOVAL OF THE PROTECTION CAP FOR THE STENT, THE STENT SYSTEM WAS INSERTED INTO A PATIENT. STENT POSITION COULD NOT BE CONFIRMED UNDER ANGIOGRAPHY. STENT WAS DETECTED TO BE DISLODGED FROM THE DELIVERY SYSTEM OUTSIDE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10929539 ↗MalfunctionAug 31, 2020Failure to Advance; Failure to Advance
THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR THE TREATMENT OF A CALCIFIED LESION. AFTER PRE-DILATATION AND IMPLANTING OF TWO OTHER ORSIRO STENTS, THE COMPLAINT DEVICE COULD NOT PASS THE LESION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10473351 ↗MalfunctionJul 1, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT. DURING UNPACKING THE STENT DISLODGED FROM BALLOON.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10219925 ↗MalfunctionJun 22, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED TO TREAT A LESION IN THE RCA. THE ORSIRO COULD NOT PASS THE LESION AND IT WAS DECIDED TO REMOVE IT. DURING REMOVAL IT WAS NOTED THAT THE STENT DISLODGED FROM THE BALLOON AND STAYED INSIDE THE LESION. A BALLOON WAS USED TO PICK-UP THE DISLODGED STENT AND THE STENT WAS DEPLOYED IN THE PROXIMAL RCA.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10181324 ↗MalfunctionJun 19, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR USE. DURING UNPACKING THE STENT WAS FOUND DISLODGED INSIDE THE PROTECTOR.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10176815 ↗MalfunctionJun 15, 2020Material Deformation; Material Deformation
THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR USE. UPON UNPACKING AND BEFORE INSERTING THE DEVICE INTO THE GUIDING CATHETER A STENT DEFORMATION WAS DETECTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10155365 ↗MalfunctionJun 8, 2020Material Deformation; Material Deformation
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT OF A MODERATELY CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN THE RCA. DURING THE PROCEDURE A STENT DEFORMATION WAS DETECTED AND THE UNEXPANDED STENT WAS WITHDRAWN FROM PATIENTS BODY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10131339 ↗MalfunctionJun 8, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED TO TREAT A LESION (100 PERCENT STENOSIS DEGREE) IN THE LAD. AFTER IMPLANTING THE FIRST ORSIRO THE COMPLAINT ORSIRO 3.0/26 WAS INTRODUCED THROUGH A GUIDEPLUS II ST BUT COULD NOT CROSS THE LESION. ADDITIONAL PRE-DILATATION WAS DONE. AFTER THREE FURTHER ATTEMPT WITH THE SAME DEVICE THE STENT DISLODGED AND REMAINED IN THE FEMORAL ARTERY. THE PATIENT WAS DISCHARGED HOME.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10131229 ↗
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- XIENCE Sierra™ 1550350-33Abbott Vascular Inc. · Coronary drug-eluting stent1 recall32 reports
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- Resolute Onyx™ RONYX30015UXMedtronic, Inc. · Coronary drug-eluting stent3 deaths73 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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