AvigoTM 103-0606-200Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00847536004764), received between Oct 21, 2019 and Sep 9, 2022 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2022Break; Break

  MEDTRONIC RECEIVED A REPORT THAT THE AVIGO GUIDEWIRE BROKE IN THE PATIENT'S BODY, AND A THROMBECTOMY STENT WAS USED TO REMOVE IT. THE GUIDEWIRE WAS REPLACED, AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THE PATIENT DID NOT EXPERIENCE ANY INJURY.  THE PATIENT WAS UNDERGOING TREATMENT FOR ACUTE ISCHEMIC STROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15388273 ↗
• MalfunctionAug 6, 2021Break; Break

  MEDTRONIC RECEIVED A REPORT THAT THE GUIDE WIRE WAS BROKEN DURING THE SURGERY AND THE BLOOD VESSEL WAS TORTUOUS. BECAUSE THE PATIENT HAD HIV, THE BROKEN PART COULD NOT BE REMOVED. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12287245 ↗
• MalfunctionMar 30, 2021Material Puncture/Hole; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AVIGO GUIDEWIRE THAT PUNCTURED THE ECHELON CATHETER; IT WAS OBSERVED THE GUIDEWIRE EXITED THE CATHETER BEFORE REACHING THE TIP. THE PATIENT WAS UNDERGOING AN ANEURYSM EMBOLIZATION PROCEDURE TO TREAT AN ANEURYSM IN THE ANTERIOR CEREBRAL ARTERY. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT ALL DEVICE WERE PREPARED AND THE CATHETER FLUSHED PER THE INSTRUCTIONS FOR USE (IFU). DURING ADVANCEMENT, THE AVIGO GUIDEWIRE EXITED THE DISTAL END OF THE ECHELON CATHETER LUMEN PROXIMAL TO THE MARKER BAND AND IT WAS DETERMINED THE CATHETER WAS RUPTURED/BROKEN. THERE WAS NO FRICTION FELT DURING DELIVERY. THERE WAS NO OTHER DAMAGE OBSERVED TO THE ECHELON CATHETER. THE ECHELON CATHETER WAS REPLACED BY A COMPETITOR'S DEVICE TO CONTINUE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11591311 ↗
• MalfunctionNov 12, 2020Break; Break

  MEDTRONIC RECEIVED A REPORT THAT DURING REASONABLE USE, THE TIP OF THE GUIDEWIRE WAS BROKEN. THE PATIENT WAS UNDERGOING EMERGENCY THROMBECTOMY, AND THERE WAS NO PATIENT INJURY AS A RESULT OF THE EVENT.

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

  MAUDE report 10833514 ↗
• MalfunctionSep 4, 2020Break; Break

  MEDTRONIC RECEIVED A REPORT THAT THE TIP OF THE AVIGO GUIDEWIRE BROKE. NO ADDITIONAL EVENT INFORMATION WAS PROVIDED AT THE TIME OF THE REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10496201 ↗
• MalfunctionApr 24, 2020Break; Break

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AVIGO GUIDEWIRE THAT WAS NOT FUNCTIONING PROPERLY AND BROKE AFTER REMOVAL FROM THE PATIENT. IT WAS REPORTED THAT WHEN THE SURGEON USED THE GUIDEWIRE TO GO HIGH, THERE WAS AN ISSUE AND IT WAS CONCERNING THAT THE GUIDEWIRE WOULD BREAK. THE SURGEON RETURNED THE GUIDEWIRE INTO THE CATHETER AND REMOVED FROM THE PATIENT. THE GUIDEWIRE BROKE AFTER REMOVAL FROM THE PATIENT. IT WAS REPLACED BY A COMPETITOR'S PRODUCT TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT SUSTAIN ANY HARM OR INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9997163 ↗
• InjuryApr 8, 2020Break; Break

  MEDTRONIC RECEIVED REPORT THAT DURING ACCESSING OF THE LEFT INTERNAL CAROTID ARTERY (ICA), THE AVIGO GUIDEWIRE COULD NOT BE PUSH UP (ADVANCED). THE AVIGO GUIDEWIRE WAS RETRIEVED AND NOTICED TO HAVE THE DISTAL TIP (AROUND 3-4MM) BROKEN. THE DISTAL SECTION OF THE AVIGO GUIDEWIRE WAS LEFT INSIDE THE VESSEL. (VESSEL LICA TORTUOUS). THE PATIENT WAS REPORTED TO HAVE ASYMPTOMATIC.

  Patient problems: Foreign Body In Patient

  MAUDE report 9941967 ↗
• MalfunctionDec 3, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION THROUGH MEDWATCH FORM THAT THERE WAS AN INTERNAL EMBOLIZATION OF LINEAR RADIOPAQUE MATERIAL WITHOUT VESSEL OCCLUSION, REGIONAL SPASM, OR EXTRAVASATION. IT WAS ALLEGED THAT THIS MATERIAL REPRESENTS A FRAGMENT FROM THE 014 AVIGO WIRE THAT MIGHT HAVE BEEN SUSTAINED FROM RESISTANCE MET ON THE INITIAL ATTEMPT TO PASS THE WIRE THROUGH THE GUIDE CATHETER TO EXPAND THE PROXIMAL CONSTRUCT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9407018 ↗
• MalfunctionOct 21, 2019Break; Break

  MEDTRONIC RECEIVED REPORT THAT THE AVIGO GUIDEWIRES BROKE. DURING AN EMBOLIZATION PROCEDURE FOR A CEREBRAL ANEURYSM, THERE WAS A FRACTURE OF THE AVIGO GUIDEWIRE INSIDE THE LEFT INTERNAL CAROTID ARTERY WITH DISPLACEMENT OF ITS DISTAL TIP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9214378 ↗