Merit Medical Systems has initiated a Class I device recall (Z-1578-2026) for its DuraMax Chronic Hemodialysis Catheter products, specifically targeting the 16F dual-valved splittable sheath introducer component. The recall was classified on April 1, 2026, due to a design defect that may prevent the sheath from splitting as intended during hemodialysis procedures, posing serious risks of patient hemorrhage, foreign body retention, and significant procedure delays. Affected products include numerous REF numbers distributed nationwide.

Healthcare providers and dialysis centers must immediately identify any DuraMax Chronic Hemodialysis Catheters in inventory matching the affected reference numbers and quarantine those products. Clinical staff should be notified of the potential failure mode where the sheath may not split properly, leading to hemorrhage or foreign body complications. Facilities should follow Merit Medical's recall instructions and report any adverse events potentially related to this defect to FDA's MedWatch program. The recall is ongoing.