SplashWireRecalls & reported problems across all models

We found 10 models of SplashWire by Merit Medical Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 21 adverse event reports in the FDA's MAUDE database, received between Jul 25, 2023 and Nov 3, 2025 — classified as 7 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Material Separation” (11 reports).

1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

SplashWire recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. May 8, 2026Open, Classified

   Due to unsealed portions of pouches.

   Z-2517-2026 · Root cause: Process design · names 8 of these models · Recall details · FDA record ↗

Most reported SplashWire problems

SplashWire models

10 models, most reported first. Each model has its own page with its reports, recalls and device details.

• SplashWire™ 00884450529447

  Wire, guide, catheter
  1 recall15 reports
• SplashWire™ 00884450529669

  Wire, guide, catheter
  1 recall2 reports
• SplashWire™ 00884450529645

  Wire, guide, catheter
  1 recall1 report
• SplashWire™ 00884450529515

  Wire, guide, catheter
  1 recall0 reports
• SplashWire™ 00884450529553

  Wire, guide, catheter
  1 recall0 reports
• SplashWire™ 00884450529683

  Wire, guide, catheter
  1 recall0 reports
• SplashWire™ 00884450529690

  Wire, guide, catheter
  1 recall0 reports
• SplashWire™ 00884450529744

  Wire, guide, catheter
  1 recall0 reports
• SplashWire™ 00884450529591

  Wire, guide, catheter
  2 reports
• SplashWire™ 00884450529355

  Wire, guide, catheter
  1 report

Recent SplashWire adverse event reports

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

• MalfunctionNov 3, 2025Break; Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  THE ACCOUNT ALLEGES THAT DURING A PERIPHERAL INTERVENTION PROCEDURE USING A SPLASHWIRE GUIDEWIRE, THE TIP OF THE WIRE BROKE OFF INSIDE OF THE PATIENT. THE TIP WAS ABLE TO BE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23458759 ↗
• MalfunctionAug 20, 2025Material Separation; Material Separation

  THE ACCOUNT ALLEGES THAT THE COATING CAME OFF IN THE MIDDLE OF THE WIRE DURING A CROSSOVER MANEUVER. AFTER USING THE FLUSH CATHETER, THE PHYSICIAN WANTED TO GUIDE A SHEATH OVER THE WIRE, BUT THE DILATOR OUTSIDE THE PATIENT BLOCKED THE WIRE. THE PROCEDURE WAS CONTINUED WITH A NEW SPLASHWIRE AND COMPLETED SUCCESSFULLY. THERE WAS A DELAY OF APPROXIMATELY 10 MINUTES FOR THE ENTIRE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22849149 ↗
• MalfunctionJun 3, 2025Material Deformation; Material Deformation

  THE ACCOUNT ALLEGES THAT DURING THE PROCEDURE THE HYDROPHILIC COATING OF THE DEVICE BECAME COMPROMISED. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22137600 ↗
• 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 ↗
• InjuryJun 11, 2024Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem

  THE ACCOUNT ALLEGES THAT THE BLACK JACKET OF THE WIRE PEELED OFF IN THE PATIENT WHILE USING A TRAILBLAZER CATHETER AND STILL REMAINS WITHIN THE PATIENT. THE PATIENT VITALS ARE CURRENTLY STABLE. NO ADDITIONAL INFORMATION TO REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 19510732 ↗
• MalfunctionMar 27, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE ACCOUNT ALLEGES THAT DURING PREPARATION FOR A THROMBECTOMY PROCEDURE WHEN THE GUIDE-WIRE WAS BACK LOADED ONTO A GUIDE CATHETER, IT WAS OBVIOUS THAT A CLEAR REDDISH-THICK GEL WAS COLLECTING ON THE GUIDEWIRE. THE DEVICE WAS NOT USED OR INTRODUCED INTO THE PATIENT'S ANATOMY. NO PATIENT CONTACT OR INJURY TO REPORT. IT IS LIKLEY THE WIRE DID COME INTO CONTACT WITH BLOOD SOMEHOW DUE TO THE ALLEGED RED COLOR OF THE OUTER HYDROPHILIC COATING. THE WIRE WAS DISCARDED AND WILL NOT BE RETURNING FOR DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18988247 ↗
• MalfunctionMar 19, 2024Material Separation; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PROCEDURE, THE CLEAR HYDROPHILIC COATING WAS COMING OFF THE GUIDEWIRE AFTER ACTIVATING THE DEVICE FOR PROCEDURAL USE. NO PATIENT CONTACT OR INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18938071 ↗
• 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 ↗

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