Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes: 00884450529645 00884450529669 00884450529690 REF: MSW

FDA device recall Z-2517-2026 · posted 2026-06-18 · Open, Classified

Recall details

Recalling firm

Merit Medical Systems, Inc.

Reason for recall

Due to unsealed portions of pouches.

Action taken

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.

Root cause

Process design

Status

Open, Classified

Product code

DQX

Quantity affected

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,

Date initiated

2026-05-08

Date posted

2026-06-18

Location

South Jordan, UT

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