Orsiro Mission 4/40/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07640130456341), received between Jun 1, 2023 and May 26, 2026 — classified as 3 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.

• MalfunctionMay 26, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (80 % STENOSIS DEGREE) IN A MODERATELY TORTUOUS SEGMENT OF AN OSTIAL VESSEL. A PRE-DILATION OF THE LESION WAS NOT PERFORMED. THE AFFECTED DEVICE WAS INTRODUCED INTO THE PATIENT'S BODY BUT COULD NOT CROSS THE LESION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25273768 ↗
• MalfunctionJul 20, 2023Use of Device Problem; Use of Device Problem

  AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. THE STENT WAS IMPLANTED WHICH WAS A WEEK PAST EXPIRATION DATE. THAT THE DEVICE WAS EXPIRED, WAS DETECTED AFTER IMPLANTATION. THE DEVICE CAME FROM TRUNK STOCK OF THE DISTRIBUTOR IN HAWAII. THE PHYSICIAN WAS HAPPY WITH RESULT AND IS NOT OVERLY CONCERNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17363930 ↗
• MalfunctionJun 1, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. HOWEVER, THE ORSIRO MISSION STENT SEPARATED FROM THE BALLOON PLATFORM. WHEN EXITING THE TIP OF THE FORTRESS WITH THE CATHETER, THE STENT ITSELF WENT (ON ITS OWN WITHOUT THE CATHETER) DOWN THE SFA AND LODGED IN THE POPLITEAL ARTERY. AN ATTEMPT WAS MADE TO RE-ENTER THE STENT WITH A BALLOON AND TO PULL BACK THE STENT INTO THE SHEATH. THE STENT WAS RETRIEVED BACK UP THE SFA, BUT THE BALLOON LOST ITS HOLD. THE STENT DISLODGED AGAIN. FINALLY, THE STENT WAS REMOVED WITH A SNARE. THE SCRUB ADMITTED THAT SHE PULLED AT THE PROTECTIVE SLEEVE INSTEAD OF THE BLACK TIP OF THE STYLET. THIS MIGHT HAVE CAUSED THE STENT TO DISLODGE FROM THE BALLOON PLATFORM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17039423 ↗