Orsiro 2.75/26/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07640130439160), received between Jun 11, 2019 and Mar 9, 2022 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (7 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.

• MalfunctionMar 9, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION IN THE LCX. THE STENT CAME OFF THE DELIVERY BALLOON DURING PREPARATION AND WAS FOUND ON THE STERILE FIELD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13710889 ↗
• MalfunctionOct 5, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. DURING UNPACKING IT WAS DETECTED THAT NO STENT WAS ON THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12579836 ↗
• MalfunctionFeb 12, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. DURING UNPACKING THE STENT DISLODGED FROM THE BALLOON AND STAYED INSIDE THE PROTECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11324865 ↗
• MalfunctionJan 7, 2021Material Deformation; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (80 PERCENT STENOSIS DEGREE) IN A MODERATELY TORTUOUS MID TO DISTAL RCA. THE ORSIRO COULD NOT PASS THE LESION AND A DEFORMATION HAD OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11135727 ↗
• MalfunctionNov 3, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR THE TREATMENT. DURING THE ATTEMPT TO CROSS THE TARGET LESION RESISTANCE WAS FELT. DURING WITHDRAWAL OF THE DEVICE THE ORSIRO STENT DISLODGED FROM THE BALLOON. EVENTUALLY THE STENT WAS FOUND IN THE RENAL ARTERY AND WAS ADAPTED TO THE VESSEL WALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10781472 ↗
• MalfunctionApr 29, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (70 PERCENT STENOSIS DEGREE) IN A MODERATELY TORTUOUS MID LAD. THE LESION COULD NOT BE CROSSED WITH THE DEVICE. DURING WITHDRAWAL THE STENT DISLODGED FROM BALLOON. THE STENT WAS RETRIEVED WITH A SNARE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10009817 ↗
• MalfunctionDec 3, 2019Inflation Problem; Inflation Problem

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN TO TREAT A CALCIFIED LESION (99 PERCENT STENOSIS DEGREE) IN THE RCA. IT WAS NOT POSSIBLE TO INFLATE THE DELIVERY BALLOON OF THE ORSIRO STENT SYSTEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9401966 ↗
• MalfunctionDec 2, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN TO TREAT A CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN A TORTUOUS LAD. BEFORE IMPLANTING THE DEVICE IT WAS DETECTED THAT THERE WAS NO STENT ON THE BALLOON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9395757 ↗
• MalfunctionAug 6, 2019Failure to Advance; Failure to Advance

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR USE. THE ORSIRO COULD NOT CROSS THE TARGET LESION IN THE LAD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8866652 ↗
• MalfunctionJun 11, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN TO TREAT A SEVERELY CALCIFIED LESION IN A MID RCA. THE DEVICE GOT STUCK IN THE LESION. DURING ATTEMPT TO WITHDRAWAL THE DEVICE TOGETHER WITH GUIDING CATHETER AND GUIDE WIRE THE STENT DISLODGED. THE STENT WAS RETRIEVED WITH A SNARE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8689238 ↗