PhD Hemostasis Valve (Merit Medical) – manufacturing defect (2025)

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Hemostasis valve has a manufacturing defect and when used the valve cap may remain depressed, leading to potential leakage, which may result in procedure inconvenience and/or hemorrhage.

Recommended Action

Per FDA guidance

On 8/4/2025, recall notices were mailed and emailed to customers who were asked to do the following: 1) Identify affected devices, quarantine, discontinue use, and distribution. 2) Ensure that applicable personnel within your organization are made aware of this field action. 3) If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is immediately shared with them and note the quantity distributed on the customer response form. Additional distribution details may be required by health authorities. 4) Complete and return the customer response form via email to RESPONSE@merit.com 5. Return all affected lots to Merit, per the instructions in the customer response form. If you have any questions concerning this communication, please contact the firm at RESPONSE@merit.com or via phone at +1 800 356 3748, Hours: 6 am to 6 pm MST, Mon-Fri.

Distribution

As reported by FDA

AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI, DC, PR