Orsiro 4.0/15/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07640130439016), received between Jun 28, 2019 and Mar 29, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 29, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY TO SEVERELY CALCIFIED LESION IN THE MODERATELY TORTUOUS DISTAL LAD. AFTER PREDILATATION THE LESION COULD NOT BE CROSSED WITH THE DEVICE. IN REMOVING THE ORSIRO, UPON ENTERING THE GUIDING CATHETER, THE STENT DISLODGED AND REMAINED IN THE PROXIMAL LAD. A DILATATION BALLOON WAS INSERTED AND INFLATED TO CRUSH THE STENT INTO THE VESSEL WALL. THE STENT DELIVERY BALLOON WAS REMOVED WITHOUT FURTHER INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13943883 ↗
• MalfunctionOct 30, 2019Difficult to Remove; Difficult to Remove

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT. THE STENT WAS SUCCESSFULLY DEPLOYED. DURING REMOVAL OF THE DEVICE RESISTANCE WAS NOTED. THE LOT NUMBER OF THIS DEVICE IS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9257902 ↗
• MalfunctionSep 16, 2019Entrapment of Device; Entrapment of Device

  (B)(6) YEAR OLD FEMALE. THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR USE. WHILE THE ORSIRO WAS ADVANCED INTO THE GUIDING CATHETER RESISTANCE WAS FELT AND IT WAS ATTEMPTED TO REMOVE THE ORSIRO. THEREBY THE STENT DISLODGED FROM THE BALLOON AND WAS SUBSEQUENTLY FOUND INSIDE THE CATHETER. EVENTUALLY IT WAS REMOVED FROM THE PATIENTS BODY WITH MINIMAL EFFORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9071221 ↗
• MalfunctionJul 15, 2019Failure to Advance; Failure to Advance

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN TO TREAT A LESION (75 PERCENT STENOSIS DEGREE) IN A TORTUOUS LEFT MAIN. THE DEVICE COULD NOT CROSS THE LESION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8791648 ↗
• MalfunctionJun 28, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN TO TREAT A SEVERELY CALCIFIED LESION (85% STENOSIS DEGREE) IN A TORTUOUS RCA. THE STENT CAME OFF THE BALLOON SOMETIME DURING PROCEDURE AND WAS ADAPTED TO THE VESSEL WALL. A GUIDEZILLA 6F EXTENSION CATHETER WAS INVOLVED DURING PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8746012 ↗