FIELDER XT AGP140002Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04547327072854), received between Dec 11, 2015 and Dec 9, 2024 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (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. How this data works · Data updated Oct 13, 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.

• InjuryDec 9, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT ATTEMPTS WERE MADE TO ADVANCE A KNUCKLED ASAHI FIELDER XT GUIDE WIRE DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) FOR A CHRONIC TOTAL OCCLUSION (CTO) IN THE UNSPECIFIED CORONARY ARTERY BUT FAILED. DURING WITHDRAWAL ATTEMPTS OF THE FIELDER XT GUIDE WIRE, THE DISTAL SEGMENT OF THE GUIDE WIRE BROKE OFF IN THE PATIENT ARTERY. THE WIRE FRAGMENT WAS JAILED WITH AN UNSPECIFIED STENT. IT WAS INFORMED THAT THERE WERE NO ADVERSE PATIENT EFFECTS.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 20876096 ↗
• MalfunctionDec 2, 2024Material Fragmentation; Material Fragmentation

  WIRE WAS KNUCKLED AND PHYSICIAN WAS TRYING TO ADVANCE THE WIRE BUT IT WOULD NOT GO. WHEN ATTEMPTING TO REMOVE THE WIRE, THE TIP BROKE OFF IN THE PATIENT'S ARTERY. BROKEN TIP WAS JAILED WITH A STENT. NO ADVERSE AFFECT TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 20826594 ↗
• InjuryMar 19, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  USER FACILITY REPORT #: (B)(4) WAS RECEIVED ON MARCH 5, 2020. IT WAS REPORTED THAT THE TIP OF AN ASAHI FIELDER XT GUIDE WIRE BROKE OFF DURING A PCI TO TREAT AN UNSPECIFIED LESION IN THE LEFT HEART. THE GUIDE WIRE WAS USED TO SUPPORT UNSPECIFIED BALLOON AND CATHETER THAT WERE KEPT COMING OUT OF THE VESSEL. THE GUIDE WIRE WAS RETRIEVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9851810 ↗
• MalfunctionMar 6, 2020Break

  WIRE TIP BROKE OFF WHEN PHYSICIAN WAS TRYING TO SUPPORT BALLOON AND CATHETER KEPT COMING OUT OF VESSEL. DEVICE RETRIEVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9803036 ↗
• InjuryJan 8, 2019Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CHRONIC TOTALLY OCCLUDED CIRCUMFLEX CORONARY ARTERY. THE ASAHI GUIDE WIRE WAS ADVANCED TO THE TARGET LESION, BUT DURING TORQUEING OF THE GUIDE WIRE, THERE WAS TEFLON FLAKING ON THE PROXIMAL END OF THE GUIDE WIRE NEXT TO THE TUOHY. THE FLAKING OF TEFLON WAS OUTSIDE THE PATIENT ANATOMY. HOWEVER, IT WAS DECIDED TO REMOVE THE GUIDE WIRE. THE GUIDE WIRE WAS REMOVED WITHOUT ANY ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. IT WAS THEN DECIDED TO HAVE THE PATIENT SENT FOR CORONARY ARTERY BYPASS (CABG) DUE TO HAVING MULTI-VESSEL DISEASE, BUT NOT RELATED TO THE GUIDE WIRE USED OR THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8229701 ↗
• InjuryApr 20, 2018Detachment Of Device Component; Difficult to Remove; Improper or Incorrect Procedure or Method; Physical Resistance; Device Damaged by Another Device

  USER FACILITY MEDWATCH REPORT RECEIVED THAT STATES: RESISTANCE WITH THE ANATOMY WAS FELT WHEN ADVANCING A FIELDER XT WIRE. THREE STENTS WERE DEPLOYED WITHOUT DIFFICULTY; HOWEVER, RESISTANCE REMOVING THE FIELDER XT WIRE WAS FELT AND FORCE WAS APPLIED. IT NOTICED THE TIP OF THE WIRE WAS DISLODGED/UNRAVELED IN THE LEFT ANTERIOR CORONARY ARTERY (LAD). AN ATTEMPT TO USE SNARES TO REMOVE THE WIRE TIP WAS MADE AND PIECES WERE REMOVED, BUT SOME TIP REMAINED. TWO WIRES WERE THEN ADVANCED BEYOND THE WIRE TIP AND THE WIRES WERE TWISTED TO CAPTURE THE REMAINING TIP. ON THE FIRST ATTEMPT, A PIECE OF THE WIRE WAS REMOVED. ON A SECOND ATTEMPT, THE REST OF THE WIRE TIP WAS SUCCESSFULLY REMOVED. INTRAVASCULAR ULTRASOUND WAS PERFORMED IN THE LAD TO VERIFY THE STENT WAS NO LONGER IN THE VESSEL. THE 3.0X22MM MEDTRONIC RESOLUTE ONYX STENT THAT HAD BEEN DEPLOYED EARLIER IN THE CASE HAD TO BE REMOVED AND REPLACED DUE TO MANIPULATION LOOKING FOR THE WIRE PIECES. NO DAMAGE TO THE NON-ABBOTT STENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7448584 ↗
• InjuryDec 11, 2015Detachment Of Device Component; Kinked; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CHRONIC TOTAL OCCLUSION IN THE RIGHT CORONARY ARTERY. THE FIELDER XT190 GUIDE WIRE WAS CROSSED TO THE LESION; HOWEVER, KEPT HITTING THE OCCLUSION AND BOUNCING BACK. THE GUIDE WIRE WAS ABLE TO PARTIALLY ENTER THE LESION AND DURING DOTTERING OF THE GUIDE WIRE TO CROSS FULLY, THE GUIDE WIRE TIP KINKED AND SEPARATED. A SNARE DEVICE WAS USED TO SUCCESSFULLY CAPTURE THE GUIDE WIRE TIP WHICH WAS REMOVED FROM THE ANATOMY. THE PROCEDURE CONTINUED ON USING NEW DEVICES WITHOUT FURTHER INCIDENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 5290817 ↗