Orsiro 3.0/40/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07640130439443), received between Oct 8, 2019 and Oct 27, 2022 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2022Material Deformation; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION. THE STENT CAME OUT OF THE BODY WITH THE STRUT OF STENT STICKING OUT. VESSEL WAS PRE-DILATED SEVERAL TIMES. PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15680297 ↗
• MalfunctionAug 19, 2021Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. IT WAS ATTEMPTED TO INTRODUCE THE COMPLAINT INSTRUMENT INTO THE PATIENTS BODY USING AN 8F TELEFLEX GUARDIAN II NON-CLICK VERSION HEMOSTATIC VALVE BUT FAILED TO CROSS THIS VALVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12342383 ↗
• MalfunctionJun 1, 2021Difficult to Remove; Difficult to Remove

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. AFTER DEPLOYMENT OF THE STENT, THE DELIVERY SYSTEM WAS DIFFICULT TO BE REMOVED. THE BALLOON WAS DEFLATED WHICH WAS CONFIRMED BY FLOUROSCOPY. THERE WAS NO EVIDENCE OF CONTRAST MEDIUM REMAINING IN THE BALLOON. THE ENTIRE SYSTEM WAS REMOVED INCL. GUIDEWIRE AND GUIDING CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11917270 ↗
• InjuryDec 12, 2020Difficult or Delayed Positioning; Inflation Problem; Difficult or Delayed Positioning; Inflation Problem

  BIOFLOW VII STUDY: DURING THE INTRODUCTION OF A GUIDING CATHETER RESISTANCE WAS FELT AND THE CONTROL ANGIO SHOWED A RECURRENT RADIAL ARTERY PERFORATION. A BALLOON WAS INSERTED TO ASSIST AND EVENTUALLY THE CATHETER WAS WITHDRAWN INTO THE SUBCLAVIAN ARTERY TO TAMPONADE THE RECURRENT RADIAL ARTERY, WHICH WAS SUCCESSFUL. AS THE PATIENT REMAINED ASYMPTOMATIC IT WAS DECIDED TO PLACE THE ORSIRO STENT. A UNDEREXPANSION WAS NOTED AFTER IMPLANTATION AND THE STENT WAS POST DILATED A SECOND TIME. IVUS WAS PERFORMED AND DEMONSTRATED PERSISTENT MILD UNDEREXPANSION.

  Patient problems: Perforation

  MAUDE report 10996455 ↗
• MalfunctionAug 11, 2020Material Deformation; Material Deformation

  THE ORSIRO US DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR USE. DURING TREATMENT OF A TOTAL OCCLUSION BY USING A 7F EXTENSION CATHETER THE STENT GOT CAUGHT UP IN THE EDGE OF THE EXTENSION CATHETER AND WAS DEFORMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10393598 ↗
• MalfunctionAug 11, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE ORSIRO US DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR USE. WHEN REMOVING THE PROTECTIVE SHEATH THE STENT CAME OFF OF THE BALLOON IN THE SHEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10393589 ↗
• MalfunctionOct 8, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT WAS CHOSEN TO TREAT A PRE-DILATED LESION IN THE MID RCA. THE LESION COULD NOT BE CROSSED AND THE DEVICE WAS WITHDRAWN. DURING WITHDRAWAL THE STENT DISLODGED FROM BALLOON. THE STENT WAS ADAPTED TO THE VESSEL WALL WITH ANOTHER BALLOON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9167826 ↗