ASAHI Gaia PV18 PHW18R302PRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04547327106917), received between Nov 22, 2022 and May 30, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 18, 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.

• MalfunctionMay 30, 2025Material Integrity Problem; Material Integrity Problem

  LESION DETAILS: PATIENT'S SFA WAS CHRONICALLY OCCLUDED & RECONSTITUTED SOMEWHERE BETWEEN THE POPLITERAL AND TIBIAL PERONEAL TRUNK. EVENT DESCRIPTION: THE PHYSICIAN WAS SUBINTIMAL THROUGH THE SFA INTO THE POPLITEAL AND AT. HE WAS ATTEMPTING TO RE-ENTER WITH THE GAIA PV AT THE TAKE OFF OF THE AT. THE GAIA PV SEEMED BUCKLED AND COLLAPSED ONTO ITSELF. UPON TRYING TO REMOVE THE WIRE, THE TIP OF THE WIRE BEGAN TO UNRAVEL. WE WERE ABLE TO REMOVE THE WIRE VIA THE SUPPORT CATHETER WITHOUT LOSING ANY PARTS OF THE WIRE. THE PHYSICIAN WAS TORQUING THE WIRE AT A SLOW STEADY PACE AND IS VERY FAMILIAR WITH THE WIRE IN HIS ALGORITHM. REMEDIAL ACTION: THE PHYSICIAN WAS ABLE TO REMOVE THE WIRE WITHOUT ANY BREAKING APART OF ANY WIRE PIECES. POST PROCEDURE OUTCOME: THE PHYSICIAN WAS UNABLE TO REENTER THE TRUE LUMEN DISTAL TO THE CTO AND REVASCULARIZE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22119276 ↗
• InjuryMay 16, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT AN ENDOVASCULAR TREATMENT (EVT) WAS PERFORMED FOR A HEAVILY CALCIFIED AND SEVERELY FLEXUOUS CHRONIC TOTAL OCCLUSION (CTO) IN THE POPLITEAL ARTERY. AN ATTEMPT WAS MADE WITH AN ASAHI GAIA PV GUIDE WIRE RETROGRADELY FROM THE POSTERIOR TIBIAL ARTERY TO THE POPLITEAL ARTERY TO APPROACH THE CTO CAP IN THE POPLITEAL ARTERY. THE GAIA PV GUIDE WIRE WANDERED IN BETWEEN THE CTO AND THE SUBINTIMAL SPACE, AND STOPPED TORQUEING DUE TO THE ENTRAPMENT. THE PHYSICIAN TRIED SPINNING THE GUIDE WIRE TO ADVANCE THROUGH THE LESION, BUT THE GUIDE WIRE WOULD NOT MOVE. WHEN THE PHYSICIAN REMOVED THE GAIA PV GUIDE WIRE, THE WIRE BEGAN TO UNRAVEL AND GOT DETACHED, LEAVING A WIRE FRAGMENT IN THE POSTERIOR TIBIAL ARTERY. IT WAS INFORMED THAT SURGICAL TREATMENT WAS PERFORMED TO REMOVE THE FRAGMENT OF THE GAIA PV GUIDE WIRE, AND THE PATIENT WAS DOING FINE AFTERWARDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22033349 ↗
• MalfunctionMar 23, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT AN ENDOVASCULAR TREATMENT (EVT) WAS PERFORMED FOR A MILDLY CALCIFIED AND MILDLY TORTUOUS CHRONIC TOTAL OCCLUSION (CTO) IN THE ANTERIOR TIBIAL ARTERY (ATA). AFTER FEMORAL PUNCTURE, AN ASAHI GAIA PV18 GUIDE WIRE WAS ADVANCED SUBINTIMAL TO THE ATA AS THE SUPERFICIAL FEMORAL ARTERY (SFA) HAD BEEN CHRONICALLY OCCLUDED AND RECONSTRUCTED SOMEWHERE BETWEEN THE POPLITEAL ARTERY AND THE TIBIOPERONEAL TRUNK. WHEN AN ATTEMPT WAS MADE TO ENTER THE GAIA PV18 GUIDE WIRE FROM THE ATA TAKEOFF, THE GUIDE WIRE LOOKED BUCKLED AND COLLAPSED ONTO ITSELF. DURING REMOVAL ATTEMPTS, THE TIP OF THE GUIDE WIRE BEGAN TO UNRAVEL. WITH USE OF A TRAILBLAZER SUPPORT CATHETER (MEDTRONIC), THE GAIA PV18 GUIDE WIRE WAS REMOVED EX SITU WITHOUT LOSING ANY PART OF IT. THE TRUE LUMEN DISTAL TO THE CTO COULD NOT BE ACCESSED AND REVASCULARIZATION COULD NOT BE ACHIEVED. IT WAS INFORMED THAT THE PHYSICIAN TORQUED THE GUIDE WIRE AT A SLOW STEADY PACE AND WAS VERY FAMILIAR WITH THE WIRE AND ALGORITHM. IT WAS ALSO INFORMED THAT THERE WAS NO HEALTH HAZARDS CAUSED TO THE PATIENT DUE TO THE REPORTED EVENT.

  Patient problems: Intraoperative Cardiac Valve Injury

  MAUDE report 21674526 ↗
• MalfunctionNov 23, 2022Fracture; Fracture

  DURING THE PROCEDURE THE PHYSICIAN SAID THE WIRE FELT "TRAPPED" HE MOVES THE WIRE AND GOT IT TO RELEASE. WHEN HE DID THAT THE WIRE BEGAN TO UNRAVEL. HE WAS ABLE TO REMOVE THE WIRE WITHOUT ANY PIECES BEING LOST. THERE WAS NO ADVERSE REACTION TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15855556 ↗
• MalfunctionNov 22, 2022Fracture; Fracture

  IT WAS REPORTED THAT AN ASAHI GAIA PV GUIDE WIRE WAS USED FOR A PERCUTANEOUS PERIPHERAL INTERVENTION TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED, 75-90% STENOSIS IN THE UNSPECIFIED LIMB ARTERY. DURING THE PROCEDURE, THE WIRE SEEMED "TRAPPED." WHEN ATTEMPTING TO REMOVE AND RELEASE THE TRAPPED WIRE, THE WIRE BEGAN TO UNRAVEL. THE WIRE WAS ABLE TO BE REMOVED WITHOUT ANY PIECES BEING LOST. THERE WAS NO ADVERSE REACTION TO THE PATIENT. THE PATIENT WAS FINE AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15841180 ↗