SplashWire™ 00884450529669Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
All models of SplashWire (10)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450529669), received between Mar 19, 2024 and Mar 27, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Separation” (1 report).
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.
Reports received per month
Recalls naming this device
- May 8, 2026Open, Classified
Due to unsealed portions of pouches.
Z-2517-2026 · Root cause: Process design · Recall details · FDA record ↗
Most reported problems
Device problems
- Material Separation1
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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 ↗
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 · each recall links to the FDA recall notice
- 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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