Starter™ Guidewire M001491181Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729201304), received between Nov 6, 2020 and Nov 17, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 17, 2024Fracture; Fracture

  EVENT DESCRIPTION: ECN EVENT DESCRIPTION: THE HEAD OF THE HEMODYNAMICS SERVICE REPORTS THAT WHEN THE PRODUCT WAS ROTATED TO THE TABLE FOR PREPARATION, THE TIP OF THE GUIDE WAS FRACTURED. WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: THE PROBLEM WAS SOLVED BY USING ANOTHER GUIDE OF THE SAME SIZE. WHAT IS THE NEXT COURSE OF ACTION?: REPLENISH THE PRODUCT PATIENT PRESENT AT TIME OF EVENT?: YES, PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20702653 ↗
• MalfunctionFeb 2, 2023Fracture; Fracture

  EVENT DESCRIPTION: IT WAS REPORTED THAT: DIFFICULT REMOVAL OF THE GUIDEWIRE, WHICH RESULTED IN THE SEVERING OF THE GUIDEWIRE DURING REMOVAL. DURING CHECK-UP POST-PROCEDURE, THE REST OF THE GUIDEWIRE WAS POSITIONED DISTALLY TO THE IN-PLACE DRAIN. ACTIONS TAKEN IN THE HEALTHCARE FACILITY FOR PATIENT MANAGEMENT: THE DRAIN AND THE REST OF THE GUIDEWIRE HAVE BEEN REMOVED FROM THE PATIENT. WHEN REMOVING THE DRAIN: WE HAD TO CONTROL THE REMOVAL OF THE REST OF THE GUIDEWIRE. THE DEVICE WAS NOT CONSERVED.EVENT DATE: (B)(6).

  Patient problems: Insufficient Information

  MAUDE report 16282942 ↗
• MalfunctionSep 29, 2021Fracture; Fracture

  PER EMAIL, IT WAS REPORTED THAT: STARTER WIRE LOOKS DEFORMED BEFORE USE. HERE IS SOME ADDITIONAL INFORMATION ON THE GUIDEWIRE. 05AUG2021 JLC: RESPONSE RECEIVED FROM GAYATHRY N VADIVAL ON 02AUG2021 WHAT WAS THE ANATOMY LOCATION THAT THE PHYSICIAN WAS WORKING ON? LEFT MAIN TO LAD . PLEASE PROVIDE LESION DETAILS: % STENOSIS? LEFT MAIN 50%, LAD 70%. CALCIFICATION? (NOT CALCIFIED, MILD, MODERATE, SEVERE). CONCENTRIC CALCIUM IN LEFT MAIN, INTIMAL CALCIFICATION AT LAD. TORTUOSITY? (NOT TORTUOUS, MILD, MODERATE, SEVERE). NOT STATED . WHEN IS THE EXPECTED DATE THIS DEVICE WILL BE RETURNED? BY THIS MONTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12545507 ↗
• MalfunctionNov 6, 2020Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem

  UNUSABLE, KINKED GUIDEWIRE. THE WARD DOCTOR NOTICED THE PROBLEM WHEN INSERTING THE GUIDE. THERE WAS A HITCH, IT WAS NOT GOING THROUGH. THE GUIDEWIRE WOULD HAVE BROKEN AT THE "J" SHAPE EXTREMITY LEVEL. THIS IS A RECURRING PROBLEM, THIS IS THE 4TH OCCURRENCE, ALL GUIDEWIRES FROM THE SAME BATCH. NOTED CONSEQUENCES: THE PROCEDURE TIME WAS LENGTHENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10799798 ↗
• MalfunctionNov 6, 2020Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem

  UNUSABLE, KINKED GUIDEWIRE. THE WARD DOCTOR NOTICED THE PROBLEM WHEN INSERTING THE GUIDE. THERE WAS A HITCH, IT WAS NOT GOING THROUGH. THE GUIDEWIRE WOULD HAVE BROKEN AT THE "J" SHAPE EXTREMITY LEVEL. THIS IS A RECURRING PROBLEM, THIS IS THE 4TH OCCURRENCE, ALL GUIDEWIRES FROM THE SAME BATCH. NOTED CONSEQUENCES: THE PROCEDURE TIME WAS LENGTHENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10799797 ↗
• MalfunctionNov 6, 2020Material Integrity Problem; Material Integrity Problem

  UNUSABLE, KINKED GUIDEWIRE. THE WARD DOCTOR NOTICED THE PROBLEM WHEN INSERTING THE GUIDE. THERE WAS A HITCH, IT WAS NOT GOING THROUGH. THE GUIDEWIRE WOULD HAVE BROKEN AT THE "J" SHAPE EXTREMITY LEVEL. THIS IS A RECURRING PROBLEM, THIS IS THE 4TH OCCURRENCE, ALL GUIDEWIRES FROM THE SAME BATCH. NOTED CONSEQUENCES: THE PROCEDURE TIME WAS LENGTHENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10799796 ↗
• MalfunctionNov 6, 2020Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem

  UNUSABLE, KINKED GUIDEWIRE. THE WARD DOCTOR NOTICED THE PROBLEM WHEN INSERTING THE GUIDE. THERE WAS A HITCH, IT WAS NOT GOING THROUGH. THE GUIDEWIRE WOULD HAVE BROKEN AT THE "J" SHAPE EXTREMITY LEVEL. THIS IS A RECURRING PROBLEM, THIS IS THE 4TH OCCURRENCE, ALL GUIDEWIRES FROM THE SAME BATCH. NOTED CONSEQUENCES: THE PROCEDURE TIME WAS LENGTHENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10799795 ↗