Orsiro 2.5/22/140Recalls & 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
- 17
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 07640130439092), received between May 16, 2019 and Jul 28, 2021 — classified as 3 injuries, 14 malfunctions.
The most frequently reported specific device problem is “Failure to Advance” (7 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 Advance7
- Device Dislodged or Dislocated5
- Material Deformation2
- Patient Device Interaction Problem2
- Inflation Problem1
- Use of Device Problem1
Patient problems
- No Consequences Or Impact To Patient10
- No Clinical Signs, Symptoms or Conditions3
- Angina1
- No Known Impact Or Consequence To Patient1
- Restenosis1
- Vascular Dissection1
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 28, 2021Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated
AN ORSIRO DRUG ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED PRE-DILATED LESION (95 PERCENT STENOSIS DEGREE) IN THE MODERATELY TORTUOUS PROXIMAL LAD. AFTER STENTING THE PROXIMAL LESION, AN ATTEMPT WAS MADE TO PLACE A 2ND STENT DISTAL TO THE 1ST ONE, BUT THE COMPLAINT DEVICE WAS UNABLE TO CROSS THE 1ST STENT. WHEN REMOVING FROM THE GUIDE THROUGH HEMOSTATIC VALVE, IT WAS NOTICED THAT THE STENT SLIPPED IN FRONT OF BALLOON. DELIVERY SYSTEM AND STENT WERE REMOVED FROM STERILE FIELD AND A NEW ORSIRO WAS DEPLOYED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12236403 ↗MalfunctionMar 16, 2021Material Deformation; Material Deformation
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (80 PERCENT STENOSIS DEGREE) IN A SEVERELY TORTUOUS MID RCA. DURING ATTEMPTED TO DELIVER THE STENT, THE LESION COULD NOT BE CROSSED. UPON REMOVAL IT WAS NOTICED THAT THE PROXIMAL END OF THE STENT WAS DAMAGED/FLARED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11496506 ↗InjuryMar 5, 2021Patient Device Interaction Problem; Patient Device Interaction Problem
(B)(6) STUDY: AFTER NSTEMI, TREATMENT WITH 2 ORSIRO DRUG-ELUTING STENT SYSTEMS WAS PERFORMED IN 2016. ON (B)(6) 2020 PATIENT EXPERIENCED CHEST PAIN AND NSTEMI. MEDICATION WAS GIVEN. A RESTENOSIS WAS DETECTED, TREATED WITH BALLOON ANGIOPLASTY AND A NEW DES STENT.
Patient problems: Restenosis
MAUDE report 11422373 ↗MalfunctionMar 3, 2021Failure to Advance; Failure to Advance
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF THE LAD. THE LESION COULD NOT BE CROSSED WITH THE DEVICE. UPON REMOVAL, THE SHAFT APPEARED KINKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11404397 ↗InjuryOct 16, 2020Patient Device Interaction Problem; Patient Device Interaction Problem
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. THE ORSIRO WAS SUCCESSFULLY IMPLANTED. AFTER THE PROCEDURE THE PATIENT REPORTED FREQUENT CHEST PAIN AND DYSPNEA BOTH DURING EXERTION AND AT REST.
Patient problems: Angina
MAUDE report 10693190 ↗InjuryAug 12, 2020Use of Device Problem; Use of Device Problem
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT OF A NON-CALCIFIED LESION (95 PERCENT STENOSIS DEGREE) IN A MILDLY TORTUOUS CX. AFTER THE PLACEMENT OF THE STENT THERE WAS A DISTAL EDGE DISSECTION. THIS WAS COVERED WITH AN ADDITIONAL STENT.
Patient problems: Vascular Dissection
MAUDE report 10398718 ↗MalfunctionJul 9, 2020Material Deformation; Material Deformation
THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT. UPON THE UNSUCCESSFUL ATTEMPT TO CROSS THE LESION A STENT DEFORMATION WAS DETECTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10255636 ↗MalfunctionNov 21, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. STENT COULD NOT CROSS THE LESION. WHEN REMOVING THE DEVICE THE STENT CAME OFF IN THE CO-PILOT VALVE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9356831 ↗MalfunctionOct 29, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED TO CALCIFIED LESION IN A MILDLY TORTUOUS LAD. WHILE ADVANCING THE DEVICE TO THE TARGET LESION THE STENT DISLODGED. THE STENT COULD NOT BE RETRIEVED AND WAS ADAPTED TO THE VESSEL WALL WITH ANOTHER STENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9251575 ↗MalfunctionJul 24, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT. DURING LESION CROSSING THE STENT DISLODGED. AN ATTEMPT TO RETRIEVE THE STENT WAS NOT SUCCESSFUL, THEREFORE THE STENT WAS ADAPTED TO THE VESSEL WALL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8824091 ↗MalfunctionJul 23, 2019Failure to Advance; Failure to Advance
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN TO TREAT A SEVERELY CALCIFIED PREDILATED LESION IN A PROXIMAL CX. THE DEVICE COULD NOT CROSS THE LESION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8819692 ↗MalfunctionJul 23, 2019Inflation Problem; Inflation Problem
THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR USE. AFTER SUCCESSFUL LESION CROSSING IT WAS NOT POSSIBLE TO INFLATE THE BALLOON OF THE ORSIRO STENT SYSTEM. THEREFORE THE DEVICE WAS REMOVED FROM THE PATIENTS BODY AND THE PROCEDURE WAS FINISHED WITH ANOTHER DEVICE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8819688 ↗MalfunctionJul 23, 2019Failure to Advance; Failure to Advance
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN TO TREAT A SEVERELY CALCIFIED PREDILATED LESION IN A PROXIMAL LAD. THE DEVICE COULD NOT CROSS THE LESION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8819101 ↗MalfunctionJul 15, 2019Failure to Advance; Failure to Advance
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN TO TREAT CALCIFIED LESION IN A TORTUOUS LAD. THE DEVICE COULD NOT CROSS THE LESION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8791655 ↗MalfunctionJul 1, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE ORSIRO DRUG-ELUTING STENT SYSTEM COULD NOT PASS THE LESION AND THUS EVERYTHING WAS REMOVED FROM THE PATIENTS BODY. AS THE DEVICE WAS ROUTINELY CHECKED IT WAS NOTICED THAT THE STENT WAS DISLODGED FROM THE BALLOON OUTSIDE OF THE PATIENTS BODY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8750642 ↗MalfunctionJun 19, 2019Failure to Advance; Failure to Advance
THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR USE. AFTER PRE-DILATATION THE ORSIRO COULD NOT PASS THE CALCIFIED LESION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8712183 ↗MalfunctionMay 16, 2019Failure to Advance; Failure to Advance
THE ORSIRO DRUG-ELUTING STENT SYSTEM COULD NOT PASS THE SEVERELY TORTUOUS AND MILDLY CALCIFIED LESION IN THE MEDIAL LAD.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8617817 ↗
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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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