Orsiro Mission 3.5/26/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07640130456150), received between Sep 7, 2023 and Jun 10, 2026 — classified as 1 injury, 3 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 18, 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 10, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION IN A MODERATELY TORTUOUS SEGMENT OF A MEDIAL VESSEL. IT IS UNKNOWN IF A PRE-DILATION OF THE LESION WAS PERFORMED. THE AFFECTED DEVICE WAS INTRODUCED INTO THE PATIENT'S BODY BUT COULD NOT CROSS THE LESION. THE INTERVENTION WAS COMPLETED BY USING ANOTHER STENT. THE COMPLAINT DEVICE WAS NOT RETURNED FROM THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25453263 ↗
• MalfunctionDec 16, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. THE STENT FELL OFF THE BALLOON PRIOR TO IMPLANTATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20939337 ↗
• InjuryOct 16, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF THE PROXIMAL LAD. IMMEDIATELY AFTER PROCEDURE AN IN-STENT THROMBOSIS OCCURRED. PATIENT DEVELOPED CHEST PAIN. RE-BALLOONING OF THE STENT WAS PERFORMED AND ADDITIONAL HEPARIN WAS GIVEN. PATIENT WAS TREATED FOR HEPARIN-INDUCED THROMBOCYTOPENIA (HIT). PHYSICIAN SHARED THAT DURING THE CASE THE PATIENTS ACT WOULD BE 182, GIVE HEPARIN WOULD GO TO 350 THEN WHEN RE-CHECKED AGAIN WOULD BE BACK DOWN TO 180.

  Patient problems: Chest Pain; Thrombosis/Thrombus

  MAUDE report 20468091 ↗
• MalfunctionSep 7, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT, BUT THE STENT DISLODGED FROM THE BALLOON WHEN THE PACKAGING STYLET WAS REMOVED FROM THE COMPLAINT INSTRUMENT. THIS OCCURRED OUTSIDE OF THE PATIENT DURING THE PREPARATIONS FOR THE INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17698983 ↗