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RecallWatchMedical Device Safety
Class IIOngoingZ-2517-2026

Merit Medical Systems, Inc. recalls Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes: 00884450529645 0…

Merit Medical Systems, Inc.South Jordan, UT, United StatesReported Jun 24, 2026 · 24 days ago
Legal News Analyst ·

Reason for recall

Due to unsealed portions of pouches.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes: 00884450529645 00884450529669 00884450529690 REF: MSWSTDA35180 UDI-DI codes: 00884450529645 00884450529669 REF: MSWSTDA35260EX UDI-DI code: 00884450529683 REF: MSWSTDA3580 UDI-DI codes: 00884450529645 00884450529690 00884450529744 REF: MSWSTDS35150 UDI-DI codes: 00884450529690 00884450529744 REF: MSWSTFA35260EX UDI-DI code: 00884450529447 REF: MSWSTFA3580 UDI-DI code: 00884450529515 REF: MSWSTFS35150 UDI-DI code: 00884450529553 The Merit Hydrophilic Guide Wire is intended to be used in the peripheral vascular system to facilitate the placement of devices during diagnostic and interventional proceduresREF
    UDI-DI codeREF MSWSTDA35150
    48 affected lots
    K3410951K3420005K3420006K3420007K342010600884450529669K342000500884450529690
    +40 moreK3420006MSWSTDA3518000884450529645K340512100884450529669K3405121K3405126K3405127K3405128K3405129K3405130K3410953K3420010MSWSTDA35260EX00884450529683K3405122K3410937K3410958MSWSTDA358000884450529645K340525700884450529690K340525700884450529744K3405257MSWSTDS3515000884450529690K342008200884450529744K3420082K3420101MSWSTFA35260EX00884450529447K3405261MSWSTFA358000884450529515K3420079MSWSTFS3515000884450529553K3399729

What the firm is doing

On 05/08/2026, the firm sent via FedEx Express an "U.S. URGENT MEDICAL DEVICE RECALL NOTICE" to inform customers that internal review identified that certain devices manufactured during a defined time period may have an incomplete seal in the pouch of the Merit SplashWire Hydrophilic Steerable Guide Wire. Customer are instructed to: 1. Immediately determine if any of the devices identified in the attached Customer Response Form (CRF) are within their facility. 2. A picture of the SplashWire Hydrophilic Steerable Guide Wire Hydrophilic Steerable Guide Wire is attached to help them identify the product. 3. Immediately discontinue the use of the affected lots of the SplashWire Hydrophilic Steerable Guide Wire. 4. Ensure that applicable personnel within their organization are made aware of this recall. 5. If the product has been further distributed to other facilities, institutions, or manufacturers, ensure this notice is immediately shared with them and note the quantity distributed on the CRF. Additional distribution details may be required by health authorities. 6. Fill out, scan and email the completed Customer Response Form to Customer Service at RESPONSE@merit.com within 10 business days. All affected product shipped to them must be accounted for on the CRF. 7. Immediately return all affected lots in their possession to Merit, per the instructions in the attached CRF. 8. When requesting replacement for the SplashWire Hydrophilic Steerable Guide Wire please utilize the table for the replacement part number and contact RESPONSE@merit.com, when they provide their completed Customer Response Form. For questions - contact your Merit Sales Representative or Merit Customer Service via email at RESPONSE@merit.com or via phone at +1 800 356 3748 | Hours: 6 am to 6 pm MST | Mon-Fri.

DistributionShow details

Worldwide - U.S. Nationwide distribution in the states and territory AL, AZ, CA, FL, GA, IA, ID, IL, IN, KS, MA, MD, ME, MI, MN, MO, MS, NC, NH, NJ, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, and Puerto Rico. The countries of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Guatemala, Ireland, Italy, Kazakhstan, Kenya, Netherlands, Norway, Portugal, Spain, Sweden, and Switzerland.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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