Orsiro Mission 2.5/15/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07640130455948), received between Jan 20, 2022 and Jul 7, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2026Device Dislodged or Dislocated

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A CALCIFIED LESION IN A TORTUOUS SEGMENT OF THE BIFURCATION LCX/OM1 WHERE A PREVIOUSLY IMPLANTED STENT WAS PRESENT. PRE-DILATION WAS PERFORMED USING A 2.0/12 MINI TREK BALLOON. THE AFFECTED DEVICE WAS INTRODUCED INTO THE PATIENT'S BODY AND ADVANCED TOWARDS THE TARGET LESION, BUT GOT CAUGHT AT THE PREVIOUSLY IMPLANTED STENT. AS A RESULT, THE STENT WAS STRIPPED OFF THE BALLOON. THE PHYSICIAN WAS ABLE TO SECURE THE STENT TO THE VESSEL WALL AT THE SITE WHERE IT HAD BECOME DISLODGED USING A 2.5/10 MEDTRONIC EUPHORA BALLOON. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25729859 ↗
• MalfunctionApr 28, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION IN AN UNSPECIFIED 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 25014373 ↗
• MalfunctionMar 24, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION (90 % STENOSIS DEGREE) IN A MODERATELY TORTUOUS SEGMENT OF THE MEDIAL CORONARY 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 24679246 ↗
• MalfunctionMar 17, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION (90 % STENOSIS DEGREE) IN A SEGMENT OF THE PROXIMAL 1ST DIAGONAL ARTERY. A PRE-DILATION OF THE LESION WAS PERFORMED WITH NC BALLOONS AND SCORING BALLOONS. THE AFFECTED DEVICE WAS INTRODUCED UNDER USE OF A GUIDELINER GUIDING EXTENSION CATHETER INTO THE PATIENT'S BODY BUT COULD NOT CROSS THE LESION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24615440 ↗
• MalfunctionMar 12, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEMS WERE SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (90% STENOSIS DEGREE) IN A MODERATELY TORTUOUS SEGMENT OF THE MID 1ST DIAGONAL ARTERY. AFTER PRE-DILATATION, THE ORSIRO MISSION 2.5/35 WAS DEPLOYED AT THE TARGET LESION. AFTER POST-DILATATION, THE SECOND ORSIRO MISSION (COMPLAINT DEVICE) SHOULD HAVE BEEN INSERTED DISTAL TO THE FIRST STENT BUT COULD NOT PASS THE PREVIOUS IMPLANTED STENT. THE DEVICE WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24577869 ↗
• MalfunctionJan 9, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (75 % STENOSIS DEGREE) IN A MODERATELY TORTUOUS SEGMENT OF THE MEDIAL LCX. PRE-DILATION OF THE LESION WAS PERFORMED. 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 24017599 ↗
• MalfunctionJun 5, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN A MODERATELY TORTUOUS PART OF THE OSTIAL CX. WHILE DELIVERING THE DEVICE, THE STENT DISLODGED FROM THE DELIVERY SYSTEM. NOT HAVING THE ABILITY TO SNARE THE STENT IT WAS CRUSHED AGAINST THE WALL OF THE CX AND STENTED OVER BY ANOTHER ORSIRO MISSION STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22151921 ↗
• MalfunctionDec 17, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. DISTAL RCA BALLOONED WITH A 2.0/12 COMPLIANT BALLOON SUCCESSFULLY. THE ORSIRO MISSION STENT WAS ATTEMPTED TO BE DELIVERED TO THE DISTAL RCA. JR4 GUIDE DID NOT SUPPORT THE DELIVERY, AND THE STENT EDGE GOT CAUGHT ON THE TIP OF THE GUIDE AND WAS STRIPPED OFF THE DELIVERY BALLOON. THE STENT WAS LEFT UNDEPLOYED AT THE TIP OF THE GUIDE. SEVERAL ATTEMPTS WERE MADE TO RETRIEVE THE UNDEPLOYED STENT, BUT ALL WERE UNSUCCESSFUL. THE UNDEPLOYED STENT WAS FINALLY MOVED TO A DISTAL MARGINAL BRANCH WITH AN UNINFLATED BALLOON AND LEFT UNDEPLOYED IN THE BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20957266 ↗
• MalfunctionSep 19, 2024Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION WITH 95 PERCENT STENOSIS DEGREE. IT WAS DIFFICULT TO CROSS THE LESION. THE STENT CAME OFF THE BALLOON BUT WAS STILL CONTAINED ON THE WIRE. THE STENT WAS SUCCESSFULLY DEPLOYED BY INSERTING A 1.0 BALLOON FOLLOWED BY A 1.5 THEN FINAL POST DEPLOYMENT WITH A 2.5 BALLOON. NO INJURY OR ADVERSE EVENTS WITH THE PATIENT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20262116 ↗
• MalfunctionApr 11, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MILDLY TORTUOUS PROXIMAL CX. IT WAS NOT POSSIBLE TO ADVANCE THE DEVICE THROUGH THE GUIDING CATHETER. THUS, IT WAS WITHDRAWN FROM THE PATIENTS BODY, AND IT WAS NOTICED THAT THERE WAS NO MORE STENT ATTACHED ON THE DELIVERY BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14074379 ↗
• MalfunctionJan 20, 2022Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. THE CALCIFIED LESION COULD NOT BE CROSSED WITH THE DEVICE. THE DEVICE WAS INTRODUCED 2 TIMES BUT COULD NOT BE DELIVERED. THEN, A 7F GUIDELINER WAS USED. A 3RD ATTEMPT WAS MADE TO DELIVER THE STENT BUT AGAIN WAS UNSUCCESSFUL. AFTER REMOVAL OF THE DEVICE, A STENT DEFORMATION WAS DETECTED. ANOTHER DEVICE WAS USED TO COMPLETE THE INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13307066 ↗