SplashWire™ 00884450529591Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
All models of SplashWire (10)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450529591), received between Jun 11, 2024 and Nov 3, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Material Integrity Problem” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Integrity Problem2
- Break1
- Fracture1
- Material Deformation1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, 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 ↗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 ↗
Other Wire, guide, catheter devices
- HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II 1009664Abbott Vascular Inc. · WIRE, GUIDE, CATHETER321 reports
- SYNCHRO 14 M00313010Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls220 reports
- PressureWire™ C12059Lightlab Imaging, Inc. · WIRE, GUIDE, CATHETER1 death296 reports
- SYNCHRO 2 M00326410Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls155 reports
- ENROUTE .014" Guidewire 11686-01Silk Road Medical, Inc. · Wire, Guide, Catheter2 deaths228 reports
- ARROW IPN035915Teleflex Incorporated · WIRE, GUIDE, CATHETER217 reports
- OmniWire Pressure guide wire 89185Philips Image Guided Therapy Corporation · Wire, Guide, Catheter1 recall1 death160 reports
- ARROW IPN055780Teleflex Incorporated · Wire, guide, catheter4 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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