Orsiro 3.5/30/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07640130439245), received between Jun 19, 2019 and Mar 7, 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 7, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. THE DEVICE WAS INTRODUCED INTO PATIENTS BODY, BUT DURING INFLATION THE STENT WAS NOT VISIBLE. THE BODY WAS SCREENED BUT WITH NO SUCCESS. FINALLY, THE STENT WAS FOUND ON THE STYLET OUTSIDE PATIENTS BODY. ANOTHER STENT WAS USED TO COMPLETE THE INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13683712 ↗
• MalfunctionMay 13, 2021Material Deformation; Material Deformation

  THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR THE TREATMENT. DESPITE ASSISTANCE OF A GUIDELINER, THE LESION COULD NOT BE CROSSED WITH THE DEVICE. AFTER REMOVAL IT WAS DETECTED THAT THE STENT WAS DAMAGED AND UNABLE TO BE REINSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11816507 ↗
• MalfunctionSep 17, 2019Deflation Problem; Deflation Problem

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT OF CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN THE MEDIAL RCA. AFTER PLACING THE STENT IT TOOK 3 MINUTES TO DEFLATE THE DELIVERY BALLOON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9076059 ↗
• MalfunctionJul 15, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AFTER DIRECT STENTING THE ORSIRO COULD NOT PASS THE SEVERELY CALCIFIED LESION IN THE RCA AND WAS THEREFORE REMOVED FROM THE PATIENT'S BODY. DURING REMOVAL THE STENT DISLODGED FROM THE BALLOON. EVENTUALLY THE DISLODGED STENT WAS COVERED AND TACKED INTO PLACE WITH ANOTHER BALLOON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8791641 ↗
• MalfunctionJun 19, 2019Failure to Advance; Failure to Advance

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN TO TREAT A CALCIFIED LESION (50% STENOSIS DEGREE) IN A MID RCA. THE DEVICE WAS UNABLE TO CROSS THE LESION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8712192 ↗