Orsiro Mission 2.25/13/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07640130455870), received between May 13, 2022 and Jun 5, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (8 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (85 % STENOSIS DEGREE) IN A MODERATELY TORTUOUS SEGMENT OF THE PROXIMAL RIM. 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 "DUE TO THE SEVERE CALCIFICATION".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25405793 ↗
• MalfunctionJun 3, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF AN UNSPECIFIED LESION IN THE MEDIAL RCA. IT IS UN-KNOWN 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25373558 ↗
• MalfunctionJun 3, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF AN UNSPECIFIED LESION IN AN UNKNOWN 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25373556 ↗
• MalfunctionApr 10, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION IN A SEGMENT OF AN UNDEFINED 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24843938 ↗
• MalfunctionApr 10, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (85 % STENOSIS DEGREE) IN A MODERATELY TORTUOUS SEGMENT OF THE OSTIAL OM. A PRE-DILATION OF THE LESION WAS 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 24838890 ↗
• MalfunctionMar 13, 2026Device Dislodged or Dislocated

  THE ORSIRO MISSION WAS USED TO TREAT A MODERATELY CALCIFIED LESION (90% STENOSIS DEGREE) IN A SEVERELY TORTUOUS SEGMENT OF THE DISTAL LCX. AT THE DISTAL TIP OF A STENT IMPLANTED MORE THAN A YEAR EARLIER, THE ORSIRO MISSION LIKELY CAUGHT ON THE PROXIMAL EDGES AND DETACHED FROM THE BALLOON. SINCE IT WAS STILL ATTACHED TO THE GUIDEWIRE, THE STENT WAS PULLED INTO THE DISTAL LEFT MAIN TRUNK, WHERE IT WAS DILATED TO 4.0 MM, CREATING A TEMPORARY STENT FROM THE DISTAL LEFT MAIN TRUNK TO THE PROXIMAL LCX. TREATMENT OF THE DISTAL LCX WAS THEN ABANDONED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24589699 ↗
• MalfunctionMar 11, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (99 % STENOSIS DEGREE) IN A MILDLY TORTUOUS SEGMENT OF THE MEDIAL RCA. A PRE-DILATION OF THE LESION WAS 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 24573732 ↗
• MalfunctionJan 23, 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 THE MEDIAL TO DISTAL RCA/PDA. 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 24159219 ↗
• MalfunctionJan 9, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION WITH 90 % STENOSIS DEGREE IN A SEGMENT OF THE DISTAL LAD. PRE-DILATION OF THE LESION WAS PERFORMED AT 6 ATM. THE AFFECTED DEVICE WAS INTRODUCED INTO THE PATIENT'S BODY BUT COULD NOT CROSS THE LESION. THE COMPLAINT DEVICE WAS DISCARDED AT THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24019214 ↗
• MalfunctionNov 19, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE ORSIRO MISSION STENT CAME OFF THE DELIVERY BALLOON DURING DEVICE PREPARATION. ANOTHER STENT WAS USED FROM COMPETITOR TO PROCEED WITH THE INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20726743 ↗
• MalfunctionJul 1, 2024Use of Device Problem; Use of Device Problem

  ON (B)(6) 2024, A LESION (90 PERCENT STENOSIS DEGREE) IN A MODERATELY TORTUOUS SEGMENT OF THE MEDIAL OM WAS TREATED. THE AFFECTED PRODUCT (EXPIRY DATE 19 APRIL 2024) WAS SUCCESSFULLY IMPLANTED 59 DAYS AFTER THE EXPIRY DATE. IT WAS NOTED THAT THE CIRCULATOR IN THE CASE DID NOT CHECK THE EXPIRATION DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19651265 ↗
• MalfunctionApr 5, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO MISSION DRUG-ELUTING STENT WAS SELECTED FOR A TREATMENT OF A SEVERELY CALCIFIED LESION IN A SEVERELY TORTUOUS PART OF THE DISTAL LAD. AFTER PRE-DILATION, THE AFFECTED DEVICE WAS INTRODUCED INTO THE PATIENTS BODY DURING WHICH THE STENT WAS STRIPPED FROM THE CATHETER. THE STENT WAS BEING PUSHED THROUGH 5.5F GUIDELINER WHEN IT EMBOLIZED. IT WAS DISCOVERED IN THE ANATOMY PROXIMAL TO THE LESION AND BALLOONED INTO THE VESSEL WALL. A 2.25/26 ORSIRO WAS THEN PLACED OVER THE CRUSHED STENT FOR STABILIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19051331 ↗
• MalfunctionMay 13, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN THE MODERATELY TORTUOUS RCA. WHEN ADVANCING THE DEVICE THROUGH THE GUIDING CATHETER, THE STENT STRIPPED OFF THE BALLOON. THE STENT WAS FOUND IN THE PROXIMAL RCA AND WAS CRUSHED ADAPTED TO THE VESSEL WALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14401739 ↗