Merit Medical ProGuide Chronic Dialysis Catheter Recall - Hemorrhage Risk
Summary
FDA issued a Class I recall for Merit Medical Systems ProGuide Chronic Dialysis Catheters due to a design defect in the 16F dual-valved splittable sheath introducer that may not split as intended. The defect can result in hemorrhage, foreign bodies left in patients, and procedure delays. 847 units distributed nationwide across multiple states.
What changed
FDA classified a Class I recall for Merit Medical Systems ProGuide Chronic Dialysis Catheters (Recall No. Z-1576-2026) involving 847 units. The recalled products include multiple REF numbers: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C, and DC21455550/C. The defect affects the 16F dual-valved splittable sheath introducer component, which may fail to split properly during procedures.
Healthcare providers with these devices in inventory or clinical use must immediately identify affected units, quarantine the products, and contact Merit Medical Systems to arrange return. The recall is ongoing. Failure to remove defective devices from use could result in serious patient injury including hemorrhage requiring emergency intervention, foreign body retention requiring surgical removal, and significant procedure delays.
What to do next
- Identify all affected ProGuide Chronic Dialysis Catheter REF numbers in inventory using the recalled product list
- Quarantine all affected units immediately and halt clinical use
- Contact Merit Medical Systems to arrange return of affected devices
Archived snapshot
Apr 7, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Merit Medical Systems, Inc.
Device Recalls (Class I)
← All Device Recalls (Class I) Class I Z-1576-2026 · 20260401 · Ongoing
Product
ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C, DC21455550/C
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, and procedure delay.
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, N...
Source: openFDA Enforcement API
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