OrsiroRecalls & reported problems across all models
Biotronik AG · 49 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 672
- Deaths reported
- 6
- Injuries reported
- 31
- Recalls
- 0
We found 49 models of Orsiro by Biotronik AG in the FDA's device registry (GUDID). Together they are named in 672 adverse event reports in the FDA's MAUDE database, received between Mar 29, 2019 and May 11, 2023 — classified as 6 deaths, 31 injuries, 635 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (294 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Most reported Orsiro problems
Device problems
- Device Dislodged or Dislocated294
- Failure to Advance178
- Material Deformation165
- Patient Device Interaction Problem18
- Inflation Problem13
- Difficult to Remove12
- Deflation Problem9
- Fracture9
Patient problems
- No Consequences Or Impact To Patient363
- No Clinical Signs, Symptoms or Conditions255
- No Known Impact Or Consequence To Patient11
- Vascular Dissection11
- Thrombosis/Thrombus6
- Thrombosis5
- Death4
- Insufficient Information3
Orsiro models
49 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Orsiro 2.5/40/140Coronary drug-eluting stent49 reports
- Orsiro 2.25/18/140Coronary drug-eluting stent43 reports
- Orsiro 3.5/40/140Coronary drug-eluting stent38 reports
- Orsiro 3.0/26/140Coronary drug-eluting stent37 reports
- Orsiro 2.25/26/140Coronary drug-eluting stent2 deaths36 reports
- Orsiro 2.25/22/140Coronary drug-eluting stent34 reports
- Orsiro 2.5/26/140Coronary drug-eluting stent30 reports
- Orsiro 3.5/18/140Coronary drug-eluting stent26 reports
- Orsiro 2.5/35/140Coronary drug-eluting stent23 reports
- Orsiro 2.75/18/140Coronary drug-eluting stent22 reports
- Orsiro 3.0/15/140Coronary drug-eluting stent21 reports
- Orsiro 3.5/35/140Coronary drug-eluting stent21 reports
- Orsiro 2.25/13/140Coronary drug-eluting stent18 reports
- Orsiro 2.75/40/140Coronary drug-eluting stent1 death18 reports
- Orsiro 2.5/22/140Coronary drug-eluting stent17 reports
- Orsiro 2.25/9/140Coronary drug-eluting stent15 reports
- Orsiro 2.5/15/140Coronary drug-eluting stent1 death15 reports
- Orsiro 3.0/18/140Coronary drug-eluting stent1 death14 reports
- Orsiro 4.0/13/140Coronary drug-eluting stent13 reports
- Orsiro 4.0/18/140Coronary drug-eluting stent13 reports
- Orsiro 2.5/18/140Coronary drug-eluting stent12 reports
- Orsiro 3.0/22/140Coronary drug-eluting stent1 death11 reports
- Orsiro 3.0/13/140Coronary drug-eluting stent10 reports
- Orsiro 2.25/15/140Coronary drug-eluting stent10 reports
- Orsiro 2.75/26/140Coronary drug-eluting stent10 reports
- Orsiro 2.5/13/140Coronary drug-eluting stent9 reports
- Orsiro 3.5/13/140Coronary drug-eluting stent9 reports
- Orsiro 2.5/9/140Coronary drug-eluting stent8 reports
- Orsiro 3.0/9/140Coronary drug-eluting stent8 reports
- Orsiro 2.5/30/140Coronary drug-eluting stent8 reports
- Orsiro 2.25/30/140Coronary drug-eluting stent7 reports
- Orsiro 3.0/30/140Coronary drug-eluting stent7 reports
- Orsiro 3.0/40/140Coronary drug-eluting stent7 reports
- Orsiro 2.75/15/140Coronary drug-eluting stent6 reports
- Orsiro 4.0/15/140Coronary drug-eluting stent5 reports
- Orsiro 3.5/26/140Coronary drug-eluting stent5 reports
- Orsiro 3.5/30/140Coronary drug-eluting stent5 reports
- Orsiro 3.0/35/140Coronary drug-eluting stent5 reports
- Orsiro 4.0/22/140Coronary drug-eluting stent4 reports
- Orsiro 4.0/26/140Coronary drug-eluting stent4 reports
- Orsiro 2.75/13/140Coronary drug-eluting stent3 reports
- Orsiro 2.75/30/140Coronary drug-eluting stent3 reports
- Orsiro 4.0/40/140Coronary drug-eluting stent3 reports
- Orsiro 2.75/9/140Coronary drug-eluting stent2 reports
- Orsiro 3.5/9/140Coronary drug-eluting stent2 reports
- Orsiro 3.5/15/140Coronary drug-eluting stent2 reports
- Orsiro 3.5/22/140Coronary drug-eluting stent2 reports
- Orsiro 2.75/22/140Coronary drug-eluting stent1 report
- Orsiro 4.0/35/140Coronary drug-eluting stent1 report
Recent Orsiro adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 11, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. THE STENT CAME OFF THE BALLOON. IT WAS ASSUMED THAT THE STENT HAD BEEN DISLODGED INSIDE THE LESION, BUT IT COULD NOT BE LOCATED IN PATIENTS BODY. EVENTUALLY, THE DISLODGED STENT WAS DISCOVERED STILL ATTACHED TO THE STYLET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16916144 ↗MalfunctionJan 9, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. THE COMPLAINT INSTRUMENT WAS INTRODUCED INTO THE PATIENTS BODY USING AN ABBOTT COPILOT BLEEDBACK CONTROL VALVE, BUT THE DEVICE HAD TO BE WITHDRAWN FROM THE PATIENT. DURING REMOVAL OF THE COMPLAINT INSTRUMENT THE STENT WAS STRIPPED OFF THE BALLOON BY THE COPILOT BLEEDBACK CONTROL VALVE. THE STENT WAS RETRIEVED FROM THE PATIENT AND BOTH THE STENT AND THE DELIVERY SYSTEM WERE DISCARDED AT THE HOSPITAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16121998 ↗MalfunctionJan 4, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. DURING AN EXTREMELY DIFFICULT AND COMPLEX TREATMENT OF THE PROXIMAL CX, THE STENT DISLODGED AND WAS NOT FOUND. IT IS PRESUMED THAT THE STENT REMAINED IN PATIENT, CRUSHED WITHIN THE STENTED PORTION OF THE PROXIMAL CX DURING POST DILATATIONS. 6F AND 7F GUIDELINER V3 CATHETERS WERE USED DURING PROCEDURE. FOLLOW-UP IMAGING SHOWED 0 PERCENT RESIDUAL STENOSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16096189 ↗MalfunctionJan 4, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. WHEN REMOVING THE MANDRIL, THE STENT DISLODGED AND REMAINED ON THE MANDRIL. THE DEVICE WAS NOT USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16096175 ↗MalfunctionOct 27, 2022Material Deformation; Material Deformation
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION. THE STENT CAME OUT OF THE BODY WITH THE STRUT OF STENT STICKING OUT. VESSEL WAS PRE-DILATED SEVERAL TIMES. PATIENT IS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15680297 ↗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 3, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. THE ORSIRO WAS INSERTED INTO THE PATIENTS BODY, NOT KNOWING THAT THE STENT WAS NOT ON THE BALLOON, BUT HAD FALLEN OFF ON THE BACK TABLE BEFORE INSERTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15528419 ↗MalfunctionAug 8, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. INITIALLY, THE DEVICE DID NOT CROSS THE LESION. WHEN REMOVING IT FROM PATIENTS BODY, THE STENT REWRAPPED. THE PROXIMAL EDGE OF STENT IS EXTREMELY CLOSE TO CLIP ON DELIVERY SYSTEM. UDI (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15183115 ↗MalfunctionAug 8, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. PRE-DILATION OF PROXIMAL CIRCUMFLEX WITH 2.0 COMPLIANT BALLOON. OSTIUM WAS NOT PRE-DILATED. ATTEMPTED TO PASS 2.25X15 ORSIRO WHICH CAUGHT RESISTANCE IN OSTIUM OF CIRCUMFLEX, UNABLE TO ADVANCE PAST DISTAL LEFT MAIN. CATHETER WAS REMOVED AND INSPECTED, STENT WAS NOT RETAINED. FLURO REVEALED STENT IN DISTAL LEFT MAIN. A COMPLIANT 2.0 BALLOON WAS INSERTED AND AIDED TO PASS STENT INTO THE CIRCUMFLEX WHERE IT WAS ULTIMATELY DEPLOYED IN THE PROXIMAL VESSEL THAT CONTAINED THE TARGET LESION. UDI (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15183099 ↗MalfunctionJul 26, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. UPON UNPACKING AND REMOVING THE PROTECTOR CAP, THE STENT DISLODGED FROM THE BALLOON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15103762 ↗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 ↗MalfunctionJul 19, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION WITH 75 PERCENT STENOSIS DEGREE IN THE LCX. THERE WAS A PRE-EXISTING LEFT MAIN/LAD STENT THAT COVERS THE OSTIUM OF LCX. WHEN THE ORSIRO STENT WAS ATTEMPTED TO CROSS THE LESION, THE STENT CAME OFF THE BALLOON AND SLID BACK ONTO THE SHAFT OF THE STENT DELIVERY SYSTEM. STENT AND AND DELIVERY SYSTEM WERE REMOVED FROM PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15056596 ↗MalfunctionJul 5, 2022Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation
AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION OBSERVED IN RCA. PRE-DILATATION WAS PERFORMED BY USING A SCORING BALLOON WITH GUIDE EXTENSION SUPPORT. AN ATTEMPT WAS MADE TO PLACE THE ORSIRO, BUT IT WAS REMOVED FROM THE BODY DUE TO RESISTANCE BEFORE THE LESION. AT THAT TIME, THE STENT WAS DEFORMED, AND IT WAS JUDGED THAT IT HAD SLIGHTLY DISLODGED. ANOTHER DEVICE WAS USED TO COMPLETE THE INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14919639 ↗MalfunctionJul 5, 2022Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated
THE SEVERELY CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN THE MILDLY TORTUOUS LAD WAS TREATED WITH AN WOLVERINE CUTTING BALLOON. AFTERWARDS, IT WAS ATTEMPTED TO PLACE THE ORSIRO DRUG-ELUTING STENT SYSTEM, BUT THE LESION COULD NOT BE PASSED. THEREFORE, A GUIDEPLUS EL EXTENSION CATHETER WAS USED TO BRING THE ORSIRO TO THE FRONT OF THE LESION. IT WAS TRIED TO PLACE THE ORSIRO BUT THE STENT WAS STILL ON THE BALLOON BUT SLIGHTLY OUT OF PLACE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14919638 ↗MalfunctionJun 29, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
A SEVERELY CALCIFIED VESSEL WITH MODERATE TORTUOSITY WAS PRE-DILATED WITH COMPLIANT AND NON-COMPLIANT BALLOONS WITH SUPPORT FROM 6F GUIDELINER. IT WAS REPORTED THAT A CONSIDERABLE AMOUNT OF FORCE WAS APPLIED IN ATTEMPT TO CROSS THE LESION. THE STENT WAS NOTED ON FLUOROSCOPY TO BE DISLODGED FROM MARKERS AND PUSHED BACK ONTO THE CATHETER. THE CATHETER WAS WALKED OUT OVER THE WIRE WHERE THE STENT COMPLETELY DISLODGED FROM THE CATHETER INTO THE CO-PILOT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14851812 ↗
Other Biotronik AG products
All Biotronik AG devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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