Orsiro 2.25/15/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07640130438965), received between May 9, 2019 and Jan 9, 2023 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• 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WAS INTRODUCED INTO THE PATIENTS BODY USING AN ABBOTT COPILOT BLEEDBACK CONTROL VALVE, BUT THE DEVICE HAD TO BE WITHDRAWN FROM THE PATIENT.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 ↗
• 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 ↗
• MalfunctionApr 27, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. THE PROXIMAL AND MID RCA WERE PRE-DILATED AND TWO STENTS WERE PLACED. AFTERWARDS IT WAS DETERMINED THAT THE DISTAL RCA REQUIRED A STENT AS WELL. THE STENT WAS ATTEMPTED TO BE PLACED, BUT IT WAS UNABLE TO CROSS THE LESION. WHEN WITHDRAWING THE DEVICE THE STENT WAS CAUGHT IN THE STENT STRUT OF THE PROXIMAL STENT. THE GUIDELINER WAS ADVANCED TO THE STENT AND THIS CAUSED THE STENT TO DISLODGE. THE DISLODGED STENT WAS SUCCESSFULLY CRUSHED IN THE ARTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11735276 ↗
• MalfunctionFeb 24, 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 LESION IN A MODERATELY TORTUOUS PROXIMAL CX. THE LESION COULD NOT BE CROSSED WITH THE DEVICE. DURING WITHDRAWAL THE STENT DISLODGED AND WAS RETRIEVED WITH ANOTHER BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11371882 ↗
• MalfunctionSep 29, 2020Fracture; Fracture

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF THE LCX. DURING WITHDRAWAL OF THE DEVICE THROUGH GUIDEZILLA EXTENSION CATHETER THE SHAFT SEPARATED FROM TIP WITH STENT. THE STENT WAS RETRIEVED FROM GUIDEZILLA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10601329 ↗
• MalfunctionDec 3, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN TO TREAT A CALCIFIED LESION (80 PERCENT STENOSIS DEGREE). THE LESION COULD NOT BE CROSSED THEREFORE THE DEVICE WAS ATTEMPTED TO BE REMOVED. WHEN ENTERING THE 5F GUIDE THE STENT DISLODGED AND WAS ADAPTED TO THE VESSEL WALL. MEDWATCH UF/IMPORTER REPORT # (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9401974 ↗
• MalfunctionSep 16, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN TO TREAT SEVERE CALCIFIED LESIONS (90 PERCENT STENOSIS DEGREE) IN THE PROXIMAL/MID AND DISTAL RCA. THE DEVICE COULD NOT PASS THE PROXIMAL LESION. DURING WITHDRAWAL THE STENT DISLODGED FROM THE BALLOON AND REMAINED INSIDE THE PROXIMAL LESION. A BALLOON CATHETER WAS USED TO ADAPT THE STENT AGAINST THE VESSEL WALL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9071219 ↗
• MalfunctionJul 15, 2019Failure to Advance; Failure to Advance

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN TO TREAT A CALCIFIED LESION IN A PROXIMAL LAD. DESPITE SEVERAL ATTEMPTS THE DEVICE COULD NOT CROSS THE LESION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8791660 ↗
• MalfunctionJun 20, 2019Failure to Advance; Failure to Advance

  AFTER PRE-DILATATION THE ORSIRO DRUG-ELUTING STENT SYSTEM COULD NOT PASS THROUGH THE IN-STENT RESTENOSIS IN THE CALCIFIED RCA.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8716928 ↗
• MalfunctionMay 9, 2019Material Deformation; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED TO TREAT A CORONARY VESSEL. IT WAS REPORTED THAT A STENT DEFORMATION OCCURRED AND THE STENT WAS NOT USED. NO DETAILS ABOUT PRE-DILATATION OR LESION DETAILS WERE PROVIDED YET.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8597380 ↗