Angiographic Guide WireRecalls & reported problems across all models

We found 8 models of Angiographic Guide Wire by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 34 adverse event reports in the FDA's MAUDE database, received between Jun 7, 2018 and Sep 22, 2023 — classified as 34 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (15 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Angiographic Guide Wire problems

Angiographic Guide Wire models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Angiographic Guide Wire 008631

  WIRE, GUIDE, CATHETER
  15 reports
• Angiographic Guide Wire 007042

  WIRE, GUIDE, CATHETER
  5 reports
• Angiographic Guide Wire 007044

  WIRE, GUIDE, CATHETER
  4 reports
• Angiographic Guide Wire 007447

  WIRE, GUIDE, CATHETER
  4 reports
• Angiographic Guide Wire 007042

  Wire, guide, catheter
  3 reports
• Angiographic Guide Wire 008632

  WIRE, GUIDE, CATHETER
  1 report
• Angiographic Guide Wire 008944

  WIRE, GUIDE, CATHETER
  1 report
• Angiographic Guide Wire 010388

  WIRE, GUIDE, CATHETER
  1 report

Recent Angiographic Guide Wire adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2023Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ANGIOGRAPHIC GUIDEWIRE DURING A CARDIAC PROCEDURE. THE DEVICE WAS NOT INSPECTED BEFORE USE. RESISTANCE WAS NOT NOTED DURING DELIVERY OF THE DEVICE. IT WAS REPORTED THAT THE OUTER SPIRALED LAYER OF THE WIRE UNRAVELED AT THE DISTAL END WHERE THERE IS A GAP BETWEEN THE SPIRAL LAYERS. THE ISSUE OCCURRED WHILE REMOVING THE WIRE FROM THE NON-MEDTRONIC GUIDE CATHETER OUTSIDE THE PATIENT, AFTER THE DEVICE HAD BEEN INSIDE THE PATIENT. THE DEFORMATION AND DETACHMENT WERE NOTED AFTER THE DEVICE WAS REMOVED. RESISTANCE WAS NOT NOTED DURING WITHDRAWAL OF THE DEVICE. THE DETACHED PORTION OF THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE GUIDE CATHETER AND DISCARDED. IT WAS ALSO DETAILED THAT THE SAME ISSUE OCCURRED WITH A NON-MEDTRONIC GUIDEWIRE AT THE BEGINNING OF THE PROCEDURE. THERE WAS NO INJURY TO THE PATIENT AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17797012 ↗
• MalfunctionMar 2, 2023Peeled/Delaminated; Material Integrity Problem; Peeled/Delaminated; Material Integrity Problem

  AN ATTEMPT WAS MADE TO USE ONE ANGIOGRAPHIC GUIDEWIRE IN A PROCEDURE. IT WAS REPORTED THAT THE COATING ON THE J TIP OF THE GUIDEWIRE WAS RUBBING OFF. SEVEN UNUSED ANGIOGRAPHIC GUIDEWIRES WITH THE SAME LOT WERE RETURNED TO MEDTRONIC. THE ANGIOGRAPHIC GUIDEWIRES ARE STORED IN AN AIRCONDITIONED ROOM, THE SAME ENVIRONMENT AS STERILE STOCK. NO PATIENT INJURY REPORTED.

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

  MAUDE report 16467574 ↗
• MalfunctionFeb 22, 2023Peeled/Delaminated; Material Integrity Problem; Peeled/Delaminated; Material Integrity Problem

  AN ATTEMPT WAS MADE TO USE TWO ANGIOGRAPHIC GUIDEWIRES. A 6FR JL4 GUIDE CATHETER WAS IN USE. THE GUIDEWIRES WERE USED WITHIN A DIAGNOSTIC CATHETER VIA FEMORAL ACCESS. THE GUIDEWIRES WERE MOISTENED PRIOR TO USE, NOT WIPED. IT WAS REPORTED THAT THE COATING ON THE J TIP OF THE GUIDEWIRES WAS RUBBING OFF. RESISTANCE FELT WRONG AND IT WAS DECIDED TO PULL EVERYTHING OUT. ONCE REMOVED IT WAS NOTED THAT THE COATING HAD GATHERED. THE COATING CAME OFF DURING THE PROCEDURE AND BLOCKED THE CATHETER. THE ANGIOGRAPHIC GUIDEWIRES ARE STORED IN AN AIRCONDITIONED ROOM, THE SAME ENVIRONMENT AS STERILE STOCK. NO PATIENT INJURY WAS REPORTED.

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

  MAUDE report 16415634 ↗
• MalfunctionFeb 22, 2023Peeled/Delaminated; Material Integrity Problem; Peeled/Delaminated; Material Integrity Problem

  AN ATTEMPT WAS MADE TO USE TWO ANGIOGRAPHIC GUIDEWIRES. A 6FR JL4 GUIDE CATHETER WAS IN USE. THE GUIDEWIRES WERE USED WITHIN A DIAGNOSTIC CATHETER VIA FEMORAL ACCESS. THE GUIDEWIRES WERE MOISTENED PRIOR TO USE, NOT WIPED. IT WAS REPORTED THAT THE COATING ON THE J TIP OF THE GUIDEWIRES WAS RUBBING OFF. RESISTANCE FELT WRONG AND IT WAS DECIDED TO PULL EVERYTHING OUT. ONCE REMOVED IT WAS NOTED THAT THE COATING HAD GATHERED. THE COATING CAME OFF DURING THE PROCEDURE AND BLOCKED THE CATHETER. THE ANGIOGRAPHIC GUIDEWIRES ARE STORED IN AN AIRCONDITIONED ROOM, THE SAME ENVIRONMENT AS STERILE STOCK. NO PATIENT INJURY WAS REPORTED.

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

  MAUDE report 16415631 ↗
• 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 ↗
• MalfunctionAug 23, 2021Entrapment of Device; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Entrapment of Device; Deformation Due to Compressive Stress; Detachment of Device or Device Component

  AN ATTEMPT WAS MADE TO USE AN ANGIOGRAPHIC GUIDE WIRE AND A LAUNCHER GUIDE CATHETER TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS LESION IN THE DISTAL LEFT MAIN (LM) CORONARY ARTERY. THE DEVICES WERE NOT INSPECTED. THE LESION WAS PRE-DILATED. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICES. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE WIRE TIP WAS FORMED BY THE PHYSICIAN. IT WAS REPORTED THAT A DEVICE DETACHMENT OCCURRED ON THE WIRE IN VIVO AND THAT THE DEVICE WAS TRAPPED IN THE PATIENT. AFTER THE STENT PLACEMENT THE PHYSICIAN WAS UNABLE TO PROCEED WITH THE LAUNCHER GUIDE CATHETER BECAUSE IT WAS STUCK IN THE WIRE. IT WAS STATED THAT AFTER MULTIPLE ATTEMPTS A KINK OCCURRED IN THE GUIDE CATHETER AND THE WIRE KINKED AND BROKE AT THE DISTAL TIP, WITH 3 CM OF THE TIP REMAINING IN THE ARTERY. THE FRAGMENT WAS NOT REMOVED AS THE PHYSICIAN CONSIDERED THAT THE BODY WOULD CREATE TISSUE AROUND IT. NO PATIENT INJURY REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12352885 ↗
• 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 ↗
• MalfunctionFeb 19, 2021Material Deformation; Material Deformation

  DURING AN ANGIOGRAM PROCEDURE, ONE ANGIOGRAPHIC GUIDE WIRE WAS ATTEMPTED TO BE USED. IT WAS REPORTED THAT A J-TIP EXCHANGE WIRE WAS USED TO GUIDE THE PIGTAIL CATHETER INTO THE VENTRICULAR. WHEN THE J-TIP WIRE WAS REMOVED IT WAS NOTED TO HAVE THE INNER WIRE POKINGTHROUGH THE SIDE OF THE MOVEABLE EXTERIOR. IT WAS STATED THAT THE J-TIP WIRE PROTRUDED THROUGH THE EXTERIOR WALL. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11348613 ↗
• MalfunctionNov 12, 2020Material Deformation; Material Deformation

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE ANGIOGRAPHIC GUIDEWIRES TO TREAT A NON-TORTUOUS, NON-CALCIFIED LESION EXHIBITING NO STENOSIS IN THE AORTA. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. THE WIRE TIP WAS NOT 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. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STRETCHED COILS WERE NOTED AFTER THE DEVICE WAS REMOVED OUT OF THE GUIDE. IT WAS STATED THAT UPON REMOVAL A CATCH WAS FELT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

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

  MAUDE report 10827781 ↗
• MalfunctionNov 2, 2020Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE ANGIO GUIDEWIRE IN A NON CALCIFIED AND NON TORTUOUS LESION IN THE OSTIUM RCA. THERE WAS NO DAMAGE NOTED TO THE DEVICE ON INSPECTION. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. THE WIRE TIP WAS NOT FORMED. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED AND EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT AFTER REMOVAL OF THE DEVICE FROM THE PATIENT DAMAGE WAS NOTED. THE DAMAGE WAS NOTED 5-7CM FROM THE TIP OF THE DEVICE. NO RESISTANCE WAS NOTED AND EXCESSIVE FORCE WAS NOT USED DURING WITHDRAWAL OF THE DEVICE. IMAGES PROVIDED SHOW A PROTRUDING WIRE. NO PATIENT INJURY WAS REPORTED.

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

  MAUDE report 10769055 ↗
• 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 ↗
• MalfunctionJul 6, 2020Material Deformation; Material Deformation

  AN ANGIOGRAPHIC GUIDE WIRE WAS USED DURING A PROCEDURE. IT WAS REPORTED THAT THE WIRE BECAME FRAYED AND UNCOILED UPON REMOVING FROM THE PATIENT. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10231960 ↗
• MalfunctionFeb 18, 2020Material Deformation; Material Deformation

  AN ANGIOGRAPHIC WIRE (PLI 10) WAS USED DURING AN AORTIC STENOSIS CASE, DURING WHICH A STRAIGHT EXCHANGE WAS EMPLOYED THROUGH A NON MEDTRONIC PIGTAIL CATHETER. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE WIRE TIP WAS NOT FORMED BY THE PHYSICIAN AS IT WAS A 0.038 STRAIGHT WIRE. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THE WIRE UNRAVELED IN THE PATIENT. ALL OF THE DEVICE WAS REMOVED FROM THE PATIENT. THE PATIENT IS ALIVE WITH NO INJURY. A SECOND WIRE (PLI 30) FROM THE SAME LOT WAS OPENED AFTER THE CASE. THE WIRE DETACHED AT THE DISTAL END DURING INSPECTION, WHILE BEING PULLED ON. THE SECOND WIRE WAS NOT USED IN THE CASE AND WAS NOT IN CLINICAL USE. TWO ADDITIONAL UNOPENED WIRES LOT#: GFCV3917 WERE RECEIVED. PLI 20 ADDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9719231 ↗
• MalfunctionJan 23, 2020Material Deformation; Material Deformation

  IT WAS REPORTED IN PE 703553375 0.035 X 145CM PTFE GUIDE WIRES BECAME DEFORMED DURING SEVERAL PROCEDURES. IT WAS REPORTED THAT THE OUTER CORE OF THE WIRE SEPARATED FROM THE INNER CORE OF THE WIRE. THERE WAS NO IMPACT TO THE PATIENT AND THEIR CURRENT STATUS IS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9620084 ↗

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