Orsiro 2.25/13/140Recalls & reported problems
Biotronik AG · Class 3 · Implant
All models of Orsiro (49)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 18
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 07640130438903), received between May 17, 2019 and Feb 8, 2022 — classified as 18 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 18, 2026.
Most reported problems
Device problems
- Device Dislodged or Dislocated11
- Failure to Advance7
- Difficult to Remove1
- Material Deformation1
Patient problems
- No Consequences Or Impact To Patient16
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 8, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. THE ORSIRO WAS REMOVED FROM THE PROTECTION RING. AS THE PROTECTIVE STYLET WAS BEING REMOVED FROM THE TIP, THE ENTIRE STENT BECAME DISLODGED AND SLID OFF THE BALLOON. A DIFFERENT STENT WAS SELECTED, AND THE PROCEDURE CONTINUED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13480841 ↗MalfunctionDec 30, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A VERY CALCIFIED LESION IN THE RCA. AFTER PRE-DILATATION THE TARGET LESION COULD NOT BE CROSSED AND THE ORSIRO CAME OFF IN THE OSTIUM OF THE RCA. EVENTUALLY THE STENT COULD BE RETRIEVED BY USING A BALLOON CATHETER. AN ATHRECTOMY WAS THEN PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11098013 ↗MalfunctionSep 2, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT OF A MODERATELY CALCIFIED LESION IN A MODERATELY TORTUOUS LAD. DURING ATTEMPT TO DELIVER THE DEVICE RESISTANCE WAS FELT IN THE 5.5 F GUIDELINER AND THE DEVICE WAS REMOVED. THE STENT DISLODGED BUT COULD BE RETRIEVED. STENT AND DELIVERY SYSTEM WERE DISCARDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10484040 ↗MalfunctionAug 13, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. THE LESION COULD NOT BE CROSSED AND THE DEVICE WAS REMOVED. WHEN THE DEVICE WAS READY TO LOAD AGAIN IT WAS DISCOVERED THAT THERE WAS NO STENT ON THE BALLOON. THE STENT WAS FOUND IN THE CO-PILOT HEMOSTATIC VALVE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10404929 ↗MalfunctionApr 10, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION IN THE OM. DURING THE PROCEDURE THE STENT DISLODGED FROM BALLOON.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9949255 ↗MalfunctionFeb 17, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR THE TREATMENT. WHILE IT WAS ATTEMPTED TO CROSS A PREVIOUSLY IMPLANTED STENT RESISTANCE WAS FELT. THUS THE STENT WAS REMOVED FROM THE PATIENT AND UPON REMOVAL IT WAS DETECTED THAT THE STENT WAS NOT ON THE DELIVERY BALLOON.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9717087 ↗MalfunctionFeb 10, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN TO TREAT A CALCIFIED LESION (100 PERCENT STENOSIS DEGREE) IN A TORTUOUS LAD. THE LESION COULD NOT BE CROSSED WITH THE DEVICE. AFTER WITHDRAWAL IT WAS DETECTED THAT NO STENT WAS ON THE BALLOON. THE STENT WAS NOT FOUND, NEITHER ON THE TABLE NOR IN PATIENTS BODY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9689392 ↗MalfunctionNov 12, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR THE TREATMENT OF A CALCIFIED AND TORTUOUS LESION. BEFORE IT WAS POSSIBLE TO DEPLOY THE ORSIRO THE STENT DISLODGED FROM THE BALLOON. THEREFORE IT WAS REMOVED FROM THE PATIENTS BODY WITH A THREADER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9310798 ↗MalfunctionNov 12, 2019Failure to Advance; Failure to Advance
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. DESPITE PREDILATATION THE DEVICE DID NOT CROSS THE LESION. THE SHAFT WAS KINKED BEFORE IT WAS ABLE TO BE DELIVERED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9310776 ↗MalfunctionOct 22, 2019Failure to Advance; Failure to Advance
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN TO TREAT A SEVERELY CALCIFIED LESION (95 PERCENT STENOSIS DEGREE) IN THE TORTUOUS MID LAD. AFTER PRE-DILATATION THE ORSIRO COULD NOT PASS LESION. AN EXTENSION CATHETER WAS USED BUT THE STENT STILL DIDN'T CROSS. UPON ANOTHER PRE-DILATATION AND IMPLANTATION OF AN 2.75/15 ORSIRO THE COMPLAINT INSTRUMENT WAS RE-INSERTED BUT COULDN'T CROSS THE IMPLANTED STENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9221665 ↗MalfunctionSep 3, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE ORSIRO DRUG ELUTING STENT SYSTEM WAS CHOSEN TO TREAT A SEVERELY CALCIFIED LESION IN A TORTUOUS SEGMENT OF THE MEDIAL LCX OM BRANCH BY DIRECT STENTING. THE ORSIRO COULD NOT PASS THE LESION AND WAS WITHDRAWN. A GUIDELINER WAS INSERTED AND THE ORSIRO WAS REINSERTED BUT THE TARGET LESION COULD NOT BE CROSSED. DURING WITHDRAWAL INTO THE GUIDELINER THE STENT DISLODGED FROM THE BALLOON. EVENTUALLY THE DISLODGED STENT WAS EXPANDED IN THE LCX BY USING ANOTHER BALLOON.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8958341 ↗MalfunctionAug 26, 2019Difficult to Remove; Difficult to Remove
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT OF A STENOSIS (70 PERCENT STENOSIS DEGREE) IN A PROXIMAL OM. WITHOUT PRE-DILATATION THE STENT WAS SUCCESSFULLY DEPLOYED WITH A PRESSURE ABOVE RBP. DURING REMOVAL OF THE DEVICE RESISTANCE WAS NOTED AND THE USED 6F GUIDING CATHETER HAS SHIFTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8932822 ↗MalfunctionJul 15, 2019Failure to Advance; Device Dislodged or Dislocated; Material Deformation; Failure to Advance; Device Dislodged or Dislocated; Material Deformation
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN TO TREAT A LESION (100 PERCENT STENOSIS DEGREE) IN A VERY TORTUOUS RCA. AFTER PRE-DIALTATION THE DEVICE COULD NOT CROSS LESION. AFTER WITHDRAWAL THE STENT DISLODGED OUTSIDE PATIENT'S BODY AND APPEARED TO BE DEFORMED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8791644 ↗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 8712222 ↗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 8712187 ↗MalfunctionJun 18, 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 8707917 ↗MalfunctionMay 19, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN TO TREAT A MODERATE CALCIFIED LESION IN A MILDLY TORTUOUS CORONARY VESSEL. THE STENT IN QUESTION WAS INADVERTENTLY BEING PASSES THROUGH AN EXISTING STENT SIDE BRANCH. THIS EXISTING STENT HAD BEEN PLACED 3 DAYS EARLIER, IT WAS NOT VERY VISIBLE. WHEN THE AFFECTED STENT WAS PLACED IN THE CORONARY VESSEL AND PULLED BACK IT MAY HAVE SNAGGED UP AGAINST THE PREVIOUSLY PLACED STENT AND IT FORCED THE STENT TO SLIDE OFF THE BALLOON.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8622530 ↗MalfunctionMay 17, 2019Failure to Advance; Failure to Advance
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED TO TREAT A CORONARY LESION, BUT COULD NOT CROSS. NO DETAILS ABOUT LESION DETAILS WERE PROVIDED YET.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8621548 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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