Orsiro Mission 2.75/40/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07640130456310), received between Dec 15, 2022 and Aug 28, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2026Fracture; Material Deformation; Unintended Movement

  The Orsiro Mission drug-eluting stent system was selected for treatment of a mildly calcified lesion (65% stenosis degree) in a mildly tortuous segment of the proximal RCA. During the advancement to the target lesion, resistance was met, resulting in bending and deformation of the stent struts. The device was not deployed. Subsequently, the patient moved their arm, which led to dislodgement of the guiding catheter, guidewire, and stent into the aorta. An attempt was made to retrieve all devices through the radial sheath; however, the stent together with the distal tip could not be withdrawn. A radial artery cutdown procedure was subsequently required to remove the remaining part.

  Patient problems: Foreign Body In Patient

  MAUDE report 50494942 ↗
• MalfunctionNov 21, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION IN THE MILDLY TORTUOUS PROXIMAL LAD. THE SYSTEM WAS ADVANCED INTO THE VESSEL AND DILATED. AFTER DEVICE WAS REMOVED FROM THE VESSEL, NO STENT WAS SEEN ON THE ANGIOGRAM. THE DEVICE WAS INSPECTED, AND THE STENT WAS FOUND ON THE STYLET ON THE TABLE. AN OTHER STENT WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18188712 ↗
• MalfunctionDec 15, 2022Inflation Problem; Inflation Problem

  AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. AFTER PREDILATATION OF A CALCIFIED LESION IN THE RCA, THE DEVICE WAS INSERTED, BUT WHEN INFLATING UP TO NORMAL PRESSURE, NO EXPANSION OF THE STENT WAS VISIBLE. THE DEVICE WAS REMOVED AND INSPECTED AND WAS FOUND STILL CRIMPED ON THE BALLOON. OUTSIDE PATIENTS BODY THE STENT COULD BE EXPANDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15987799 ↗