SplashWire™ 00884450529447Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00884450529447), received between Jul 25, 2023 and Aug 27, 2024 — classified as 6 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Material Separation” (9 reports).

1 FDA recall record name this device's identifier, 1 still open.

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 16, 2026.

Recalls naming this device

1. May 8, 2026Open, Classified

   Due to unsealed portions of pouches.

   Z-2517-2026 · Root cause: Process design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

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

• MalfunctionAug 27, 2024Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THE WIRE COATING AND THE WIRE TIP DETACHED WITHIN A BALLOON THAT WAS USED IN THE PATIENT. BOTH THE WIRE AND BALLOON WERE REMOVED TOGETHER AS A UNIT. NO INTERVENTION NEEDED. A NEW WIRE WAS USED TO COMPLETE THIS PROCEDURE. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20081529 ↗
• InjuryAug 27, 2024Material Frayed; Material Frayed

  THE ACCOUNT ALLEGES THAT DURING A VASCULAR ANGIOGRAM WITH INTERVENTION, THE WIRE SHREDDED WHILE IN USE. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20081526 ↗
• MalfunctionMar 12, 2024Material Separation; Material Separation

  THE ACCOUNT ALLEGES THAT WHEN INSERTING THE HYDROPHILIC GUIDEWIRE THROUGH AN ACCESS SHEATH, THE CLEAR HYDROPHILIC COATING WAS GATHERING IN FRONT OF THE VALVE. THE SHEATH WAS REMOVED, AND THE CLEAR COATING THAT COLLECTED WAS FLUSHED FROM THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18889719 ↗
• MalfunctionFeb 27, 2024Material Deformation; Material Deformation

  THE ACCOUNT ALLEGES THAT THE ACCESS SHEATH HAD TO BE REMOVED FROM THE PATIENT BECAUSE OF COATING OF THE ACCESS GUIDEWIRE WAS COLLECTING AT THE SHEATH VALVE. AFTER SHEATH REMOVAL, THE CLEAR GELATINOUS MATERIAL WAS FLUSHED FROM THE ACCESS SHEATH/SHEATH VALVE. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18789789 ↗
• InjuryFeb 27, 2024Material Deformation; Material Deformation

  THE ACCOUNT ALLEGES THAT THEY HAD AN CASE WHERE THE GUIDEWIRE COATING CAME OFF THE WIRE 3-4CM SECTION ABOUT 15-20CM FROM THE TIP DURING A PERIPHERAL LEG PROCEDURE. THE WIRE WAS PUT THROUGH A DIAGNOSTIC CATHETER AND THEN HAD A TRAILBLAZER / CROSSOVER CATHETER WAS ALSO USED FOR THIS PROCEDURE. WHEN HE TRIED TO REMOVE THE GUIDE WIRE IT WAS STICKY AND GAVE RESISTANCE. ALL INTERVENTIONAL EQUIPMENT WAS REMOVED FROM THIS PATIENT. THEY FOUND THAT THE COATING BECAME STUCK WITHIN THE GUIDE CATHETER. A NEW CATHETER WAS USED TO COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18789782 ↗
• MalfunctionFeb 22, 2024Material Deformation; Material Deformation

  THE ACCOUNT ALLEGES THAT THE CLEAR HYDROPHILIC COATING WAS COMING OFF THE WIRE WHILE BACK LOADING A CATHETER OVER THE WIRE. THERE WAS A CLEAR GELATINOUS MATERIAL GATHERING AT THE TIP OUTSIDE THE PATIENTS BODY AS IT WAS ADVANCED OVER THE WIRE. THE WIRE WAS WELL LUBRICATED. THE MATERIAL WAS REMOVED, BUT GATHERED AGAIN WHEN THE WIRE WAS ADVANCED FURTHER. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18762755 ↗
• MalfunctionFeb 21, 2024Material Deformation; Material Deformation

  THE ACCOUNT ALLEGES THAT THE CLEAR HYDROPHILIC COATING WAS COMING OFF THE WIRE WHILE BACK LOADING A CATHETER OVER THE WIRE. THERE WAS A CLEAR GELATINOUS MATERIAL GATHERING AT THE TIP OUTSIDE THE PATIENTS BODY AS IT WAS ADVANCED OVER THE WIRE. THE WIRE WAS WELL LUBRICATED. THE MATERIAL WAS REMOVED, BUT GATHERED AGAIN WHEN THE WIRE WAS ADVANCED FURTHER. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18753495 ↗
• MalfunctionFeb 21, 2024Material Separation; Material Separation

  THE ACCOUNT ALLEGED THAT THE ACCESS SHEATH HAD TO BE REMOVED FROM THE PATIENT BECAUSE THE COATING OF THE ACCESS GUIDEWIRE WAS COLLECTING AT THE SHEATH VALVE. AFTER SHEATH REMOVAL, THE CLEAR GELATINOUS MATERIAL WAS FLUSHED FROM THE ACCESS SHEATH/SHEATH VALVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18747096 ↗
• InjuryOct 19, 2023Material Separation; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PROCEDURE THE WIRE JACKET SPLIT AND SEPARATED YET REMAINED ON THE GUIDEWIRE AND WAS REMOVED AS A UNIT. NO ADDITIONAL INTERVENTION WAS NECESSARY. THE PATIENT TOLERATED THE PROCEDURE WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17965426 ↗
• MalfunctionOct 3, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A SFA INTERVENTION. THE GUIDEWIRES BLACK JACKET WAS SOMEHOW DAMAGED AND HAD STARTED TO BUNCH UP [ACCORDIONED] AT THE TIP DURING THE PERIPHERAL VASCULAR INTERVENTION. THE BLACK JACKET REMAINED ON THE GUIDEWIRE AND WAS REMOVED ALONG WITH THE GUIDIWRE. AFTER REMOVAL THE WIRE LOOKED LIKE IT WAS CUT CIRCUMFERENTIALLY. NO INTERVENTION NEEDED TO RETRIEVE ANY FOREIGN BODIES FROM THE PATIENT. PRODUCT MALFUNCTION ONLY. A COMPETITORS WIRE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17865569 ↗
• InjurySep 4, 2023Material Separation; Material Separation

  THE ACCOUNT ALLEGES THAT THE BLACK JACKET FROM THE GUIDEWIRE DETACHED WITHIN THE PATIENTS SFA. THE FOREIGN BODY WAS RETRIEVED VIA VASCULAR SNARE DEVICE FROM THE PATIENT'S SFA. THE EVENT WAS NOT LIFE-THREATENING, BUT THE PATIENT WAS HELD OVER FOR OBSERVATION FOR AN ADDITIONAL DAY BEFORE BEING DISCHARGED TO HOME. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17680510 ↗
• InjuryAug 22, 2023Material Separation; Material Separation

  THE ACCOUNT ALLEGES THAT DURING AN INTERVENTIONAL PROCEDURE, THE OUTER COATING BEGAN TO COME OFF THE WIRE DURING A CATHETER EXCHANGE. THE WIRE WAS REMOVED FROM THIS PATIENT WITHOUT FB INTRODUCTION. NO ADDITIONAL PROCEDURES WERE NECESSARY TO PREVENT PERMANENT IMPAIRMENT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17599258 ↗
• MalfunctionAug 9, 2023Material Separation; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERIPHERAL VASCULAR PROCEDURE, THE WIRE WAS WIPED CLEAN RIGHT OUT OF THE SALINE WIRE BOWL. DURING A CATHETER EXCHANGE, THE TEAM EXPERIENCED SOME DIFFICULTY IN BACKING THE CATHETER OUT OF THE BODY OVER THE GUIDE WIRE. WHEN OBSERVING THE WIRE CLOSE-UP, THE ACCOUNT ALLEGES THAT THE BLACK JACKET COATING WAS RUINED. A TORQUE DEVICE WAS USED WITH THIS GUIDE WIRE DUE TO THE PATIENT'S CALCIFIED VESSELS. A NEW GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE, WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17487618 ↗
• MalfunctionAug 9, 2023Material Separation; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A DIAGNOSTIC PERIPHERAL VASCULAR PROCEDURE AFTER REMOVING THE .035 WIRE FROM THE PATIENT IT WAS NOTED UNDER FLUOROSCOPY THAT THE BLACK JACKET WAS STARTING TO SEPARATE AT THE TIP OF THE GUIDEWIRE. THE WIRE WAS IMMEDIATELY REMOVED FROM THE PATIENT INTACT WITH NO FOREIGN BODY INTRODUCTION. A NEW WIRE WAS USED TO COMPLETE THESE PROCEDURES, WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PATIENT TOLERATED THE PROCEDURE WELL. THE WIRE WAS DISCARDED AT THE ACCOUNT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17487614 ↗
• InjuryJul 25, 2023Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  THE ACCOUNT ALLEGES THE OUTER PORTION OF THE WIRE SEPARATED DURING THE PROCEDURE. IN ADDITION, THE WIRE DID NOT STAY WET AND FELT DRY DURING THE PROCEDURE. NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17393794 ↗