Orsiro 2.25/30/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07640130439207), received between Jul 15, 2019 and Oct 19, 2021 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 19, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PHYSICIAN WAS TREATING A PATIENT AND WENT TO DEPLOY THIS 2.25/30 ORSIRO. DEVICE WAS PREPPED BUT THERE WAS NO STENT ON THE BALLOON. THEY HAD TO USE A SECOND STENT. THIS WAS ORIGINALLY REPORTED ON MDR-1028232-2021-05694, BUT THE SIZE, MODEL AND LOT NUMBER WERE INCORRECT. THAT REPORT WAS CLOSED AND THIS ONE OPENED IN ITS PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12656254 ↗
• MalfunctionFeb 3, 2020Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT OF A LESION IN THE RCA. THE LESION COULD NOT BE CROSSED WITH THE DEVICE AND WAS REMOVED. AFTER WITHDRAWAL IT WAS DETECTED THAT THE STENT WAS DEFORMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9661739 ↗
• MalfunctionNov 26, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN TO TREAT A LESION IN THE PROXIMAL CX. DURING THE PROCEDURE THE ORSIRO STENT DISLODGED FROM THE BALLOON AND WAS ADAPTED TO THE VESSEL WALL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9379993 ↗
• MalfunctionNov 21, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. AFTER REMOVING THE STENT PROTECTOR AND FLUSHING THE DEVICE IT WAS DECIDED TO PRE-DILATE THE LESION A SECOND TIME, SO THE STENT WAS ON TABLE UNDER A TOWEL. WHEN INSERTING THE STENT SYSTEM IT WAS NOTICED THAT THE STENT WAS NOT ON THE BALLOON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9356816 ↗
• MalfunctionAug 6, 2019Failure to Advance; Failure to Advance

  THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR USE. DURING LESION CROSSING THE ORSIRO COULD NOT CROSS THE SEVERELY CALCIFIED AND TORTUOUS TARGET LESION IN THE LAD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8866653 ↗
• MalfunctionJul 24, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN TO TREAT A SEVERELY CALCIFIED LESION IN A TORTUOUS RCA. DURING PROCEDURE THE STENT DISLODGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8824083 ↗
• MalfunctionJul 15, 2019Failure to Advance; Failure to Advance

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN TO TREAT A CALCIFIED LESION (99 PERCENT STENOSIS DEGREE) IN A CX. THE DEVICE COULD NOT CROSS THE PRE-DILATED LESION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8791650 ↗