OptoWire IIIRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07540184010325), received between Mar 9, 2020 and Jul 16, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2025Solder Joint Fracture; Solder Joint Fracture

  ON JUNE 16, WE WERE MADE AWARE BY THE ALBERTA HEALTH SERVICE OF A WIRE THAT BROKE INTO 2 PIECES. THE GUIDEWIRE WAS NOT FULLY INSERTED INTO THE PATIENT AND WAS REMOVED. A REPLACEMENT WIRE WAS THEN OPENED AND USED. NO SERIOUS HARM WAS REPORTED. THE EVENT OCCURRED ON JUNE 10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22520049 ↗
• MalfunctionNov 2, 2023Mechanical Problem; Mechanical Problem

  OPSENS WAS INFORMED BY THE DISTRIBUTOR THAT OPTOWIRE WAS ADVANCED INTO A SIGNIFICANTLY CALCIFIED LESION IN THE LAD, IT WAS NOTICED THAT THE WIRE WAS BROKEN WHERE PROXIMAL RADIOPAQUE SECTION STOPS. WIRE TIP WAS SAFELY REMOVED, AND PATIENT IS DOING WELL. OPSENS WAS INFORMED BY THE DISTRIBUTOR THAT OPTOWIRE WAS ADVANCED INTO A SIGNIFICANTLY CALCIFIED LESION IN THE LAD, IT WAS NOTICED THAT THE WIRE WAS BROKEN WHERE PROXIMAL RADIOPAQUE SECTION STOPS. WIRE TIP WAS SAFELY REMOVED, AND PATIENT IS DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18060648 ↗
• MalfunctionAug 30, 2023Fracture; Fracture

  THE EVENT AS DESCRIBED BY THE MEDICAL AUTHORIZATION HOLDER IN JAPAN: THE OPERATOR INITIALED CAG EXAMINATION FOR THE PURPOSE OF FFR. THE OPERATOR ADVANCED THE OPTOWIRE TO THE SITE OF SEVERE STENOSIS BUT WAS UNABLE TO CROSS THE LESION. DURING SEVERAL ATTEMPTED AT WIRING, THERE WAS NO SENSATION OF THE WIRE EXTENSION, WHICH WAS ALSO CONFIRMED BY ANGIOGRAPHIC FINDING. THE OPERATOR IMMEDIATELY PLACED A MICROCATHETER (CARAVEL) OVER THE OPTOWIRE AND RETRIEVED THE WIRE. THE GUIDEWIRE WAS SEVERED WHEN CONFIRMED OUTSIDE THE BODY. NO BROKEN WIRE REMAINED IN THE BODY. THEREAFTER, NO PCI WAS PERFORMED AND ONLY AN EXAMINATION WAS COMPLETED. THE PATIENT WAS NOT INJURED AND WAS DISCHARGED FROM THE HOSPITAL AT NORMAL SCHEDULE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17652756 ↗
• MalfunctionJul 19, 2023Unsealed Device Packaging; Unsealed Device Packaging

  BEFORE THE PROCEDURE, IT WAS NOTICED THAT THE STERILE TYWEK POUCH WAS NOT SEALED AT THE LOWER END.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17356208 ↗
• MalfunctionFeb 15, 2023Mechanical Problem; Mechanical Problem

  OPTOWIRE F1032 LOT# OW-2457B WAS PLACED IN PATIENT LAD. DPR MEASUREMENT TAKEN. WHEN REMOVING WIRE (PULLING BACK), THE DISTAL TIP (ENTIRE RADIOPAQUE SECTION) DETACHED FROM THE REST OF THE WIRE. IT WAS LODGED IN THE CORONARY THAT HAD SIGNIFICANT PLAQUE/CALCIUM. PATIENT STABLE WITH NO HEMODYNAMIC CHANGES. NO EKG CHANGES. PHYSICIAN DECIDED TO STENT THE AREA THUS STABILIZING THE WIRE IN THE CORONARY. PATIENT DID FINE WITHOUT EVENT POST PROCEDURE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16380922 ↗
• MalfunctionFeb 10, 2023Mechanical Problem; Mechanical Problem

  THE EVENT WAS REPORTED AS FOLLOWING FROM THE PHYSICIAN TO OPSENS SALES REPRESENTATIVE: THE WIRE WAS INSERTED INTO A CALCIFIED RCA AND AS THE PHYSICIAN WAS ADVANCING THE WIRE DOWN THE VESSEL, HE NOTICED THAT THE TIP WOULD NO LONGER TORQUE AND APPEARED TO BE STUCK IN A CALCIFIED LESION. WITHOUT THINKING ABOUT IT, THE PHYSICIAN PULLED SOMEWHAT FORCEFULLY ON THE WIRE AND THE WIRE CAME BACK, BUT HE NOTICED THAT THE DISTAL TIP WAS NOT ATTACHED. THE DISTAL CAP OF THE WIRE REMAINED IN THE CALCIFIED LESION AND THE THIN WIRE COIL HAD UNWRAPPED AND WAS STILL IN THE PATIENT'S RIGHT CORONARY ARTERY AND BEYOND. AFTER A FEW HOURS, MOST OF THE UNWRAPPED COIL WAS REMOVED FROM THE PATIENT, BUT A SMALL SEGMENT OF WIRE (DISTAL CAP AND COIL) WAS LEFT IN THE RCA WITH A SMALL SECTION PROTRUDING INTO THE AORTA. THE PHYSICIAN DID NOT FEEL THAT THE WIRE WAS AT FAULT AND STATED THAT HE SHOULD NOT HAVE PULLED IT FORCEFULLY WHEN THE TIP WAS INITIALLY STUCK IN THE CALCIFIED LESION. THE WIRE WAS DISCARDED AND NOT AVAILABLE FOR ANALYSIS. OPSENS WAS NOT INFORMED OF ANY PATIENT COMPLICATIONS AFTER THE INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16358531 ↗
• MalfunctionJan 15, 2021Fracture; Detachment of Device or Device Component; Material Twisted/Bent

  EVENT OCCURED IN UNITED-STATES. A GUIDEWIRE FRACTURE OCCURRED. THERE WAS NO CONSEQUENCE FOR THE PATIENT. THEY FELT A RESISTANCE/KINK WHEN THEY INTRODUCED THE GUIDEWIRE IN THE GUIDING CATHETER. THEY KEPT ADVANCING THE GUIDEWIRE AND IT BROKE AT APPROXIMATELY ON THIRD FROM THE DISTAL END. THE FRACTURE OCCURRED WHEN THE OPTOWIRE WAS STILL IN THE GUIDING CATHETER AND NOT IN THE AORTA OR CORONARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11178471 ↗
• MalfunctionMar 9, 2020Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  EVENT INFORMATION WAS OBTAINED THROUGH INTERVIEW WITH THE PHYSICIAN. FFR PROCEDURE WAS INITIATED TO ASSESS A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE GUIDEWIRE WAS POSITIONED FOR EQUALIZATION. THE GUIDEWIRE THEN STRAYED INTO A SIDE BRANCH. MILD CALCIFICATION WAS PRESENT. THE PHYSICIAN ATTEMPTED TO RETRACT THE GUIDEWIRE FROM THE SIDE BRANCH BUT REALIZED THAT THE GUIDEWIRE WAS ENTRAPPED. ATTEMPT TO RETRIEVE THE WIRE BY PULL FORCE AND USE OF A BALLOON WERE UNSUCCESSFUL. THE GUIDEWIRE TIP BROKE FROM THE PULL FORCE. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE SEPARATED PART WITH A SNARE. THE PHYSICIAN COULD NOT GRAB THE SEPARATED FRAGMENT WITH THE SNARE AND HAD TO REMOVE ALL EQUIPMENT IN ORDER TO HAVE ENOUGH ROOM TO PROPERLY OPERATE. THE PHYSICIAN COULD THEN SUCCESSFULLY RETRIEVE THE SEPARATED PART. THE FFR PROCEDURE COULD BE SUCCESSFULLY COMPLETED USING A SECOND OPTOWIRE III. NO PATIENT INJURY OCCURRED. THE PHYSICIAN CONSIDERED THAT THE ENTRAPMENT AND THE FRACTURE WERE UNEXPECTED. THE OPTOWIRE III WAS MADE AVAILABLE FOR RETURN TO OPSENS. UPON REQUEST BY OPSENS, ANGIOGRAMS WERE PROVIDED BY THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9805197 ↗