Class 2 Device Recall Splashwire Hydrophilic Guide Wire

• Date Initiated by Firm: May 08, 2026
• Date Posted: June 18, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2517-2026
• Recall Event ID: 98818
• 510(K)Number: K201595
• Product Classification: Wire, guide, catheter - Product Code DQX
• Product: 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: 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
• FEI Number: 1721504
• Recalling Firm/ Manufacturer: Merit Medical Systems, Inc.; 1600 W Merit Pkwy; South Jordan UT 84095-2416
• For Additional Information Contact: Mr. Adrian Cole; 801-253-1600
• Manufacturer Reason for Recall: Due to unsealed portions of pouches.
• FDA Determined Cause: Process design
• Action: 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.
• Quantity in Commerce: 5,004
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = DQX