Angiographic Guide Wire 007042 (UDI 00643169856714)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169856714), received between Jun 7, 2018 and Sep 22, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2021Peeled/Delaminated; Peeled/Delaminated

  DURING A PROCEDURE A 145CM J TIP ANGIO GUIDEWIRE WAS BEING USED TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. NO DAMAGE WAS NOTED TO THE PACKAGING. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING PER THE IFU. THE DEVICE WAS INSPECTED WITH NO ISSUES, THE DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES IDENTIFIED. THE WIRE TIP WAS FORMED BY THE PHYSICIAN. THE LESION WAS NOT PRE-DILATED, THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT, RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED DURING INSERTION/DELIVERY. IT WAS REPORTED THAT WHEN REMOVING THE J WIRE FROM THE DIAGNOSTIC CATHETER IN THE PATIENT, THE WIRE FELT GRITTY, THE WIRE WAS WIPED ON A GAUZE AND GREEN RESIDUE WAS REMOVED. THE DEVICE WAS REPLACED BY ANOTHER MEDTRONIC PRODUCT. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12511369 ↗
• MalfunctionJun 3, 2021Flaked; Flaked

  DURING A TAVR PROCEDURE AN ATTEMPT WAS MADE TO USE ONE ANGIO GUIDEWIRE TO TREAT A NON TORTUOUS AND NON CALCIFIED LESION. THE DEVICE WAS INSPECTED WITH NO ISSUE NOTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. THE WIRE TIP WAS NOT FORMED. RESISTANCE WAS EXPERIENCED DURING INSERTION. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THE WIRE KINKED WHEN IN THE PATIENT. DAMAGE WAS NOTED TO THE DEVICE POST REMOVAL FROM THE PATIENT. WHEN INSERTING THE WIRE INTO THE CATHETER IT WAS NOTED THAT THERE WAS A GRINDING FEELING AND ON REMOVAL IT WAS NOTICED THAT A SMALL AMOUNT OF THE COLOUR ON THE WIRE HAD FLAKED OFF. THE WIRE WAS REPLACED WITH ANOTHER WIRE AND THE TAVR CASE WAS CONTINUED WITHOUT ISSUE WITH NO HARM TO THE PATIENT. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11929296 ↗
• MalfunctionOct 14, 2020Peeled/Delaminated; Material Integrity Problem; Peeled/Delaminated; Material Integrity Problem

  ONE ANGIOGRAPHIC GUIDE WIRE WAS ATTEMPTED TO BE USED. IT WAS REPORTED THAT THE COATING WIPED OFF THE GUIDE WIRE AFTER USE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10677630 ↗
• MalfunctionJul 28, 2020Physical Resistance/Sticking

  ELDERLY MALE WITH CORONARY ARTERY DISEASE HAVING A HEART CATHETERIZATION. DURING THE PROCEDURE, THE J WIRE STUCK IN THE LOOP. HO KNOWN HARM TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10331827 ↗
• MalfunctionJun 7, 2018Kinked; Material Deformation; Kinked; Material Deformation

  TWO ANGIOGRAPHIC 0.035" WIRES WERE INTENDED TO BE USED DURING A PROCEDURE. ONLY ONE DEVICE WAS USED IN THE PATIENT. DURING THE PROCEDURE, A FEMORAL APPROACH WAS USED TO ACCESS THE OSTIUM OF THE RCA. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THERE WERE NO ISSUES NOTED TO THE DEVICES WHEN REMOVING FROM THE PACKAGING PER IFU. BOTH WIRES WERE INSPECTED AND PREPPED PER IFU WITHOUT ISSUES. THE WIRE TIPS WERE NOT FORMED BY THE PHYSICIAN. POOR STEERABILITY WAS NOTED. IT WAS ALSO NOTED DURING REMOVAL OF THE DEVICE USED IN THE PATIENT, THAT THE COILS WERE SEPARATED AND THE WIRE WAS KINKED. THE SECOND WIRE WAS TESTED OUTSIDE THE PATIENT AND KINKED. PATIENT ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7577193 ↗