Orsiro 4.0/22/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07640130439139), received between Jun 19, 2019 and Jun 17, 2021 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF THE PROXIMAL LAD. THE ORSIRO WAS STRIPPED OFF THE BALLOON BEFORE IT WAS LOADED ON THE WIRE. AS IT WAS NOT NOTICED AND THE DEVICE WAS ADVANCED TO THE TARGET LESION FOR STENT DEPLOYMENT. AFTER THE PROCEDURE (DURING CASE REVIEW) IT WAS NOTICED THAT NO STENT APPEARED TO BE ON THE BALLOON AND IT APPEARS THE STENT DID NOT ENTER THE BODY. THUS, PATIENT WAS BROUGHT BACK INTO CATH LAB AND ANOTHER STENT WAS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12016507 ↗
• MalfunctionDec 8, 2020Inflation Problem; Inflation Problem

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF THE MID LAD. DURING ATTEMPT TO DEPLOY THE STENT WITHIN PATIENT AND INFLATING THE BALLOON, THE STENT REMAINED ON THE BALLOON AND DID NOT DEPLOY. IT WAS REMOVED FROM THE PATIENT AND ANOTHER WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10969061 ↗
• MalfunctionAug 12, 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 VESSEL. DESPITE SEVERAL ATTEMPTS THE LESION COULD NOT BE CROSSED. AFTER WITHDRAWAL, IT WAS DETECTED THAT THE STENT WAS DISLODGED. THE STENT WAS FOUND KINKED INSIDE THE GUIDING CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8884512 ↗
• MalfunctionJun 19, 2019Failure to Advance; Failure to Advance

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN TO TREAT A PRE-DILATED SEVERELY CALCIFIED LESION (95% STENOSIS DEGREE) IN A PROXIMAL RCA. THE DEVICE WAS UNABLE TO CROSS THE LESION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8712217 ↗