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SplashWire recallZ-2517-2026 · Merit Medical Systems, Inc. · initiated May 8, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Merit Medical Systems, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Due to unsealed portions of pouches.

FDA root cause category: Process design

What the company 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 [email protected] 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 [email protected], when they provide their completed Customer Response Form. For questions - contact your Merit Sales Representative or Merit Customer Service via email at [email protected] or via phone at +1 800 356 3748 | Hours: 6 am to 6 pm MST | Mon-Fri.

Recall details

Recall number
Z-2517-2026
Status
Open, Classified
Initiated by the company
May 8, 2026
Posted by the FDA
Jun 18, 2026
Recalling firm
Merit Medical Systems, Inc.
Quantity
5,004
Product code
DQX
FDA submissions
K201595
Distribution
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.

Product description

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 procedures.

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

REF: MSWSTDA35150 UDI-DI code: 00884450529645 Lot Numbers: K3410951 K3420005 K3420006 K3420007 K3420106 UDI-DI code: 00884450529669 Lot Number: K3420005 UDI-DI code: 00884450529690 Lot Number: K3420006 REF: MSWSTDA35180 UDI-DI code: 00884450529645 Lot Number: K3405121 UDI-DI code: 00884450529669 Lot Numbers: K3405121 K3405126 K3405127 K3405128 K3405129 K3405130 K3410953 K3420010 REF: MSWSTDA35260EX UDI-DI code: 00884450529683 Lot Numbers: K3405122 K3410937 K3410958 REF: MSWSTDA3580 UDI-DI code: 00884450529645 Lot Number: K3405257 UDI-DI code: 00884450529690 Lot Number: K3405257 UDI-DI code: 00884450529744 Lot Number: K3405257 REF: MSWSTDS35150 UDI-DI code: 00884450529690 Lot Number: K3420082 UDI-DI code: 00884450529744 Lot Numbers: K3420082 K3420101 REF: MSWSTFA35260EX UDI-DI code: 00884450529447 Lot Number: K3405261 REF: MSWSTFA3580 UDI-DI code: 00884450529515 Lot Number: K3420079 REF: MSWSTFS35150 UDI-DI code: 00884450529553 Lot Number: K3399729

Devices named in this recall

8 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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