Verrata Plus Pressure Guide Wire 10185JPRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00845225002886), received between Mar 29, 2018 and Jun 11, 2022 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 11, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A DIAGNOSTIC CORONARY PROCEDURE, THE VERRATA 10185JP WIRE SIGNAL DISAPPEARED. A NEW VERRATA WIRE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED. DURING THE PRODUCT RETURN EVALUATION USING A MICROSCOPE, A PORTION OF THE SENSOR WAS CRACKED AND MISSING WITH NO SHARP EDGES OBSERVED. ALTHOUGH IT WAS CONFIRMED THAT THE DEVICE WAS INTACT DURING USE, IT CANNOT BE DETERMINED AT 100% BECAUSE THE MISSING SENSOR IS NOT VISIBLE TO THE NAKED EYE. THIS PRODUCT PROBLEM IS BEING SUBMITTED IN ABUNDANCE OF CAUTION DUE TO A PORTION OF THE SENSOR MISSING. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14662192 ↗
• InjuryOct 25, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT AFTER A DIAGNOSTIC CORONARY PROCEDURE, INSIDE THE BODY DURING PULLBACK, THE WIRE GOT STUCK IN THE CORONARY VESSEL AND BROKE, PARTLY IN THE PROXIMAL LAD AND PARTLY IN THE AORTA. THE OPERATOR REMOVED HALF THE WIRE FROM THE PATIENT AND THE PATIENT REQUIRED SURGICAL INTERVENTION TO REMOVE THE OTHER HALF OF THE BROKEN WIRE. NO PIECE OF THE WIRE WAS RETAINED IN THE PATIENT. THE IFR/FFR WAS SUCCESSFULLY PERFORMED AND STENTS WERE PLACED AFTER THE INTERVENTION. THE PATIENT IS REPORTEDLY DOING FINE. NO RESISTANCE NOTED DURING DELIVERY. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE MANUFACTURER'S WIRE SEPARATED IN THE PATIENT AND REQUIRED SURGICAL INTERVENTION FOR REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12689832 ↗
• MalfunctionApr 26, 2018Material Separation; Material Separation

  THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. IT WAS REPORTED THAT DURING A PLANNED CORONARY DIAGNOSTIC PROCEDURE THE MANUFACTURERS WIRE STARTED TO UNRAVEL. IT WAS FURTHER REPORTED, THE PHYSICIAN HAD THE GUIDE IN PLACE AND WIRED THE VESSEL WITH THE MANUFACTURER'S WIRE THROUGH A SEMI TORTUROUS VESSEL. IT WAS OBSERVED THE WIRE LOOKED DIFFERENT AND WAS REMOVED. NO RESISTANCE WAS OBSERVED. THE GUIDE STAYED ENGAGED, A SECOND WIRE WAS PLACED TO COMPLETE THE INTERROGATION WITH NO HARM TO THE PATIENT. ADDITIONAL INFORMATION WAS PROVIDED, THE WIRE WAS INSPECTED PRIOR TO THE PROCEDURE WITH NO DAMAGE OBSERVED. THERE WAS NO SEPARATION OR DETACHMENT AND THE WIRE WAS INTACT AND IN ONE PIECE UPON REMOVAL FROM THE PATIENT. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. A VISUAL AND MICROSCOPIC INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. KINKS AND BENDS WERE OBSERVED ALONG THE WIRE. THE DISTAL COIL WAS STRETCHED EXPOSING THE CORE WIRE. THE EXPOSED CORE WIRE AT THE DISTAL COIL BROKE AT APPROXIMATELY 23 MM FROM THE DISTAL END OF THE SENSOR HOUSING. THE REMAINING BROKEN PIECE OF THE EXPOSED CORE WIRE STAYED ATTACHED TO THE DOME. THE BROKEN PIECES OF TH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7467202 ↗
• InjuryMar 29, 2018Fracture; Stretched; Material Twisted/Bent; Fracture; Stretched; Material Twisted/Bent

  IT WAS REPORTED THE WIRE WAS RECOGNIZED BY THE SYSTEM, ZEROED AND NORMALIZED. SINCE THE WIRE WAS DIFFICULT TO CONTROL, THE PHYSICIAN DECIDED TO CHANGE THE WIRE. WHEN REMOVING THE WIRE FROM THE VESSEL, IT CAME TO A RESISTANCE. THE WIRE WAS TURNED OVER AND DIFFICULT TO REMOVE. THE REMOVAL OF THE WIRE WAS PERFORMED USING A BALLOON CATHETER. AFTER EXTRACTING THE WIRE, THE DOCTOR DISCOVERED THAT THE TIP OF THE WIRE WAS DAMAGED. IN ORDER TO CONTROL THE SITUATION, AN X-RAY IMAGE HAS BEEN DONE AND ENSURED THAT THE WIRE WAS COMPLETELY REMOVED. THE PATIENT HAD NO INJURIES AND NO CONSEQUENCES ARE TO BE EXPECTED. THE PROCEDURE WAS COMPLETED WITH A NEW WIRE. NO PATIENT INJURY. PATIENT WAS DISCHARGED AS EXPECTED; DOING VERY WELL. VESSEL: RCA 11. THIS EVENT IS BEING REPORTED BECAUSE ADDITIONAL INTERVENTION WAS USED TO REMOVE THE DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7384374 ↗