FIELDER XT AGP140302Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04547327072861), received between Oct 17, 2016 and Jul 11, 2025 — classified as 9 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJul 11, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED FOR A MODERATELY TORTUOUS, HEAVILY CALCIFIED 75-90% STENOSIS IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). INTRAVASCULAR LITHOTRIPSY (IVL) WAS PERFORMED WITH AN ASAHI FIELDER XT GUIDE WIRE ALONGSIDE OF A SHOCKWAVE BALLOON. AFTER STENTING THE LAD, THE PHYSICIAN NOTICED THAT THE TIP OF THE FIELDER XT GUIDE WIRE WAS BEHIND THE STENT. THE STENT WAS POST-DILATED AND THE WIRE TIP WAS EMBEDDED IN THE VESSEL. THE PHYSICIAN COMMENTED THAT THE PULSES FROM THE SHOCKWAVE BALLOON MOST LIKELY WEAKENED OR FRACTURED THE WIRE. IT WAS INFORMED THAT THE PATIENT WAS FINE WITHOUT ANY ISSUES AFTER THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22477313 ↗
• MalfunctionJul 1, 2025Fracture; Fracture

  INTRA VASCULAR LITHOTRIPSY WITH THE WIRE ALONGSIDE OF THE SHOCKWAVE BALLOON. AFTER STENT PLACEMENT IN THE LAD THEY NOTICED THE WIRE TIP WAS BEHIND THE STENT. THEY POST DILATED THE STENT, AND THE WIRE TIP WAS STENTED INTO THE VESSEL. THERE WERE NO PATIENT PROBLEMS DURING OR POST PROCEDURE. THE WIRE WENT TO RISK MANAGEMENT TEAM IT WILL NOT BE AVAILABLE FOR RETURN.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22378331 ↗
• InjuryMay 23, 2024Fracture; Fracture

  WIRE BECAME CAUGHT ON THE END OF THE SUPPORT CATHETER AND FRACTURED A PIECE OF THE WIRE INSIDE THE TIBIAL ARTERY. PROVIDER BELIEVED MORE DAMAGE WOULD BE DONE TRYING TO GET THE PIECE OF WIRE OUT. WIRE WAS LEFT IN PLACE WITH NORMAL FLOW AROUND IT.

  Patient problems: Foreign Body In Patient

  MAUDE report 19383675 ↗
• InjuryMay 13, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT AN ASAHI FIELDER XT GUIDE WIRE WAS USED WITH AN UNSPECIFIED SUPPORT CATHETER TO TREAT AN UNSPECIFIED LESION IN THE TIBIAL ARTERY. THE FIELDER XT GUIDE WIRE GOT STUCK IN THE DISTAL SEGMENT OF THE CONCOMITANT SUPPORT CATHETER AND FRACTURED WHILE THE GUIDE WIRE WAS BEING USED IN THE PATIENT ANATOMY. THE GUIDE WIRE FRAGMENT REMAINED IN THE TIBIAL ARTERY. BASED ON THE PHYSICIAN'S CONCERN OVER MUCH GREATER RISKS EXPECTED IF REMOVAL ATTEMPT WERE TO BE MADE, A DECISION WAS MADE TO LEAVE THE FRAGMENT IN SITU. THERE WERE NO ANOMALIES WITH THE PATIENT'S HEMODYNAMICS ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 19306557 ↗
• InjuryAug 13, 2021Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT AN ASAHI FIELDER XT WAS USED IN A PLAIN OLD BALLOON ANGIOPLASTY (POBA) TO TREAT A MILDLY TORTUOUS, HEAVILY CALCIFIED 90%-99% STENOSIS IN THE POSTERIOR TIBIAL ARTERY. DURING THE PROCEDURE, ABOUT 16CM OF ITS POLYMER JACKET CAME OFF IN THE POSTERIOR TIBIAL ARTERY AND WAS RETAINED IN THE CALCIFIED LESION. A SNARE WAS USED TO RETRIEVE THE PEELED POLYMER JACKET, BUT THE ATTEMPT WAS ENDED UNSUCCESSFULLY. THE PATIENT WAS FINALLY SENT TO SURGERY AND THEY WERE ABLE TO RETRIEVE ALMOST EVERYTHING BUT LEFT SOME FOREIGN BODY BEHIND. THE PATIENT WAS REPORTEDLY FINE AFTER THE PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12317300 ↗
• InjuryNov 9, 2020Break

  MD WAS DOING A KISSING BALLOON TECHNIQUE WITH FIELDER XT WIRE DOWN THE RAMUS BETWEEN THE BALLOONS. MD INSTRUCTED TECH TO DEFLATE THE BALLOONS AND REMOVE FIELDER XT WIRE. DURING REMOVAL OF FIELDER XT WIRE MD SAYS WIRE 'SHREDDED' AND A PIECE OF WIRE BROKE OFF AND WAS LEFT IN PATIENTS VESSEL.

  Patient problems: Foreign Body In Patient

  MAUDE report 10814400 ↗
• InjuryAug 20, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE INTERVENTION WAS TO TREAT A SEVERELY TORTUOUS, SEVERELY CALCIFIED 100% OCCLUSION IN THE LEFT PERONEAL ARTERY. AFTER DIRECTING THE GUIDE WIRE AND A NON-ASAHI MICRO CATHETER TO THE PROXIMAL CAP OF THE LESION, MULTIPLE ATTEMPTS WERE MADE TO TRAVERSE THE CO CAP AFTER WHICH THE WIRE AND MICRO CATHETER BECAME LODGED IN THE CALCIFIC BURDEN. MULTIPLE ATTEMPTS WERE MADE TO WITHDRAW THE WIRE AND MICRO CATHETER AT WHICH TIME THE TIP OF THE MICRO CATHETER AND WIRE DETACHED IN THE CALCIFIC CAP. THE REMAINING MICRO CATHETER AND WIRE WERE REMOVED AND A SNARE WAS USED TO ATTEMPT TO RETRIEVE THE WIRE AND MICRO CATHETER TIPS AT WHICH TIME THE LOOP OF THE SNARE BECAME LODGED AND BROKE OFF IN THE CALCIUM AS WELL. IT WAS DETERMINED AT THAT TIME TO STOP THE CASE. IT WAS THE PHYSICIAN'S DECISION THAT THE PATIENT'S CONDITION WAS NOT ANY WORSE THAT WHEN HE WENT IN FOR THE PROCEDURE AS HE ALREADY HAD NO FLOW.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 8913714 ↗
• MalfunctionAug 4, 2019Entrapment of Device; Detachment of Device or Device Component

  TOTALLY OCCLUDED LEFT DISTAL PERONEAL WAS SEEN ON ANGIOGRAM AFTER NORMAL ACCESS. IT WAS DETERMINED THAT THE VESSEL WAS 100% OCCLUDED AND THAT THE PHYSICIAN WOULD ATTEMPT TO INTERVENE. AFTER DIRECTING THE WIRE AND MICRO CATHETER TO THE PROXIMAL CAP OF THE LESION, MULTIPLE ATTEMPTS WERE MADE TO TRAVERSE THE CO CAP AFTER WHICH THE WIRE AND MICRO CATHETER BECAME LODGED IN THE CALCIFIC BURDEN. MULTIPLE ATTEMPTS WERE MADE TO WITHDRAW THE WIRE AND MICRO CATHETER AT WHICH TIME THE TIP OF THE MICRO CATHETER AND WIRE DETACHED IN THE CALCIFIC CAP. THE REMAINING MICRO CATHETER AND WIRE WERE REMOVED AND A SNARE WAS USED TO ATTEMPT TO RETRIEVE THE WIRE AND MICRO CATHETER TIPS AT WHICH TIME THE LOOP OF THE SNARE BECAME LODGED AND BROKE OFF IN THE CALCIUM AS WELL. IT WAS DETERMINED AT THAT TIME TO STOP THE CASE AND THE PHYSICIAN WENT TO DISCUSS WHAT OCCURRED WITH THE PATIENTS FAMILY MEMBERS.

  Patient problems: Device Embedded In Tissue or Plaque; Occlusion

  MAUDE report 8858476 ↗
• InjuryDec 19, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. THE GUIDE WIRE WAS ADVANCED TO THE TARGET LESION BUT FAILED TO CROSS DUE TO THE PATIENT ANATOMY. WHEN THE GUIDE WIRE WAS REMOVED, AND IT WAS NOTED THAT THE COILS APPEARS SEPARATED AND UNRAVELED AT THE TIP OF THE WIRE BUT WERE STILL IN ONE PIECE. A NEW GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE FINAL PATIENT OUTCOME WAS GOOD. NO ADDITIONAL INFORMATION CAN BE PROVIDED AS THE PHYSICIAN AND PROCEDURE LOG HAVE NO ADDITIONAL INFORMATION ON WHAT OCCURRED TO THE GUIDE WIRE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8182744 ↗
• InjuryNov 12, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE COATING OF AN ASAHI GUIDE WIRE CAME OFF INSIDE A CONCOMITANT NON-ASAHI BALLOON DILATATION CATHETER DURING A PCI TO TREAT A HEAVILY TORTUOUS, HEAVILY CALCIFIED LESION IN THE OM BRANCH. THE GUIDE WIRE BECAME STUCK IN THE BALLOON DURING REMOVAL DUE TO VERY TORTUOUS VESSEL. BOTH DEVICES WERE REMOVED TOGETHER AS A SINGLE UNIT. THERE WERE NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8062525 ↗
• InjuryOct 17, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN A CHRONIC TOTALLY OCCLUDED (CTO) RIGHT CORONARY ARTERY. A FIELDER XT 300 GUIDE WIRE WAS SUCCESSFUL IN CROSSING THE CTO; HOWEVER, SOMETIME DURING USE OF THE GUIDE WIRE A PERFORATION WAS OBSERVED. THE GUIDE WIRE WAS RETRACTED, BALLOON ANGIOPLASTY WAS PERFORMED AND THE PROCEDURE CONTINUED ON. AFTER PLACEMENT OF NON-ABBOTT STENTS A 3.5 X 16 MM GRAFTMASTER COVERED STENT WAS USED SUCCESSFULLY FOR TREATMENT OF THE PERFORATION. THE FINAL OUTCOME WAS GOOD. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Perforation

  MAUDE report 6034123 ↗