Merit Medical Systems, Inc. recalls DuraMax Chronic Hemodialysis Catheter
Reason for recall
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
DuraMax Chronic Hemodialysis Catheter21 codes
- 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
Lot / code information
- REF
- UDI-DI/
- Lot #
H787103028015/A:00884450794524/I3049562; H787103028025/A:00884450794531I3309371; H787103028031/A:00884450794548/I2929299, I3072553, I3154760, I3175731, I3178921, I3315957; H787103028035/A:00884450786130/I2910259 — +80 moreShow all
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
What the firm is doing
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.
DistributionShow detailsHide
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
A reasonable probability that use of the product will cause serious adverse health consequences or death.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1578-2026
- FDA 510(k) clearance · K101843The device's official FDA premarket clearance record
- FDA device classification · MSDOfficial FDA classification for this device type
- CFR regulation · 21 CFR 876.5540The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Merit Medical Systems, Inc.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
More Class I recalls
Spectra Medical Devices, LLC recalls Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection
Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be exposed to microorganisms, endotoxins, or foreign matter.…
- Vascular Access Flush Saline
- Nonconforming Material/Component
Baxter Healthcare Corporation recalls Baxter Duo-Vent Solution Set and Male Luer Lock Adapter
Baxter received customer reports of air bubbles in the drip chamber and tubing when a pressure cuff is in use or when the tubing is flushed at the fully open position.
- Intravascular Administration Set
- Under Investigation by firm
Boston Scientific Neuromodulation Corporation recalls INFINION CX LEAD KIT
Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may result in high impedance measurements or lead fractures, which may lead to inadequate stimulation, additional intervention, i…
- Totally Implanted For Pain Relief Spinal-Cord Stimulator
- Device Design