Merit Medical BioFlo Recall - Class I Design Defect
Summary
FDA issued Class I recall Z-1579-2026 for Merit Medical BioFlo DuraMax Catheter (16F dual-valved splittable sheath introducer) due to a design defect that may prevent proper splitting, potentially causing hemorrhage, foreign bodies, and procedure delays. The recall affects multiple product codes and is ongoing. US nationwide distribution confirmed to healthcare facilities.
What changed
Merit Medical Systems initiated a Class I device recall (Z-1579-2026) for BioFlo DuraMax Catheter, specifically the 16F dual-valved splittable sheath introducer. FDA determined the design defect may cause the sheath to fail to split as intended during procedures, resulting in hemorrhage, foreign bodies in the patient, and significant procedure delays. Affected products include multiple catalog numbers (H965103028011/A through H965103028051/EU). Distribution spans worldwide with US nationwide coverage to multiple states.
Healthcare providers and facilities must immediately identify affected BioFlo DuraMax Catheter products by catalog number, cease use of all affected devices, quarantine the products, and contact Merit Medical for return instructions. Distributors should identify customers who received the affected devices and notify them of the recall. This is an ongoing recall with no specified deadline, requiring immediate action due to the serious health risks associated with device malfunction.
What to do next
- Cease use of all BioFlo DuraMax Catheter products with affected REF numbers (H965103028xxx/A, H965103028xxx/EU)
- Quarantine all affected devices and do not use in procedures
- Contact Merit Medical Systems to arrange return of affected products
- Notify healthcare facilities and staff who may have received or used these 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-1579-2026 · 20260401 · Ongoing
Product
BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A, H965103028031/EU, H965103028041/A, H965103028041/EU, H965103028051/A, H965103028051/EU, H965103028...
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
Related changes
Get daily alerts for FDA: Device Recalls Class I
Daily digest delivered to your inbox.
Free. Unsubscribe anytime.
Source
About this page
Every important government, regulator, and court update from around the world. One place. Real-time. Free. Our mission
Source document text, dates, docket IDs, and authority are extracted directly from FDA.
The summary, classification, recommended actions, deadlines, and penalty information are AI-generated from the original text and may contain errors. Always verify against the source document.
Classification
Who this affects
Taxonomy
Browse Categories
Get alerts for this source
We'll email you when FDA: Device Recalls Class I publishes new changes.
Subscribed!
Optional. Filters your digest to exactly the updates that matter to you.