Merit Medical Systems, Inc.: DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A, H787103028031/A, H787103028035/A, H787103028041/A, H787103028045/A, H787103028051/A, H787103028055/A, H787103028061/A, H787103028075/A, H787103028085/A, H787103028095/A, H787103028165/A, H787103028181/A, H787103028185/A, H787103028191/A, H787103028195/A, H787103028205/A, H787103028215/A, H787103028225/A, H787103028235/A

Recall number

Z-1578-2026

Recalling firm

Merit Medical Systems, Inc.

Product

DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A, H787103028031/A, H787103028035/A, H787103028041/A, H787103028045/A, H787103028051/A, H787103028055/A, H787103028061/A, H787103028075/A, H787103028085/A, H787103028095/A, H787103028165/A, H787103028181/A, H787103028185/A, H787103028191/A, H787103028195/A, H787103028205/A, H787103028215/A, H787103028225/A, H787103028235/A

Status

Open, Classified

Initiated

2026-02-13

Posted

2026-03-26

Terminated

not on file

Reason

16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access.

Root cause

Process control

Action

On 2/13/2026, recall notices were mailed and emailed to customers who were asked to do the following: A picture of the 16F Dual-Valved Splittable Sheath Introducer is attached to help you identify the product. Place this notice and the picture on or near the affected product in your inventory (if applicable). Discontinue the use of the 16F Dual-Valved Splittable Sheath Introducer and destroy the sheath introducer at the point of use. Ensure that applicable personnel within your organization are made aware of this field action. 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 customer response form. Complete and return the customer response form via email to response@merit.com If you have any questions concerning this communication, contact the firm's 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. On 4/2/2026, revised notices were mailed to customers that included stickers to be placed on affected devices to ensure awareness of the recall.

Quantity

21,591

Distribution

Worldwide distribution: US (nationwide) to states of: TX, LA, OR, NM, MI, FL, CO, CA, GA, NC, AK, NY, PA, WI, NJ, VA, AZ, IN, KY, MO, DE, SC, MT, NE, WV, OH, MA, MN, CT, MD, KS, WA, TN, ID, UT, DC, MS, IL, OK, AL, RI, AR, NV and OUS (International) to countries of : Canada, Spain, United Arab Emirates, Brazil, Jordan, Iraq, France, Indonesia, Malaysia, Thailand, Slovakia, Colombia, Saudi Arabia, Belize, Hong Kong, Mexico, Austria, Belgium, Chile, Germany, Sweden, Ireland, Poland, Latvia, Italy, South Africa, Switzerland, Bulgaria, Peru, Argentina, Qatar, Greece, Georgia, United Kingdom, Brunei Darussalam, Ecuador, Panama, Netherlands, Venezuela, Bolivarian Republic of, Costa Rica, Viet Nam, Cayman Islands, Iran, Islamic Republic of, Australia, Nicaragua, Dominican Republic, Bolivia, Plurinational State of, El Salvador, Guatemala, Honduras, Japan

Lot, serial or model codes

REF:UDI-DI/Lot: H787103028015/A:00884450794524/I3049562; H787103028025/A:00884450794531I3309371; H787103028031/A:00884450794548/I2929299, I3072553, I3154760, I3175731, I3178921, I3315957; H787103028035/A:00884450786130/I2910259, I2910261, I2910262, I2980545, I2995795, I3021388, I3076851, I3085062, I3219446, I3219454, I3255314, I3288649, I3334618; H787103028041/A:00884450794555/I2909647, I3115465, I3178909, I3236154; H787103028045/A:00884450786161/I3004072, I3015761, I3044845, I3072554, I3108153, I3176646, I3178918, I3213147, I3219456, I3281054, I3334627; H787103028051/A:00884450794562/I2995730, I3072556, I3213145, I3219455, I3288560, I3302443; H787103028055/A:00884450794579/I3178903); H787103028061/A:00884450794586/I2929300, I2995814, I3072557, I3165105, I3207168, I3236155, I3334619; H787103028075/A:00884450794609/I2995817), I3209313, I3270826; H787103028085/A:00884450794623/I2890956, I3072561, I3108155, I3288562, I3302444; H787103028095/A:00884450794630/I2909667, I2929315, I3021151, I3098576), I3219463, I3288581; H787103028165/A:00884450794647/I3049563; H787103028181/A:00884450794661/I2929317, I3178900, I3208675; H787103028185/A:00884450786178/I2927170, I2929318, I2929319, I3002050, I3015762, I3021450, I3049572, I3085060, I3173615, I3178896, I3195157; H787103028191/A:00884450794678/I2909758; H787103028195/A:00884450786185/I2890957, I2929321, I3021395, I3049573, I3076853, I3124837, I3169030, I3213148, I3236141, I3236161, I3302447, I3343042; H787103028205/A:00884450794692/I2927146, I2995766, I3015801, I3044846, I3144026, I3219464, I3288564, I3302448; H787103028215/A:00884450794708/I3178904; H787103028225/A:00884450794715/I3044836, I3108157, I3236142, I3315958; H787103028235/A:00884450842249/I3178905;

510(k) numbers

["K101843"]

PMA numbers

not on file

Product code

MSD

Firm FEI

1721504

Firm city

South Jordan

Firm state

UT

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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