Recall of BioFlo DuraMax Catheters Due to Design Defect
Merit Medical Systems, Inc. is recalling 47,153 units of BioFlo DuraMax Catheters because of a potential design defect that may cause the sheath introducer not to split properly, leading to risks like hemorrhage.
What this fda recalls alert tells you, and what most readers miss
This notice was issued by FDA on April 8, 2026 and geographically references Worldwide. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.
Most readers skim an alert like this, check whether they are personally affected, and move on. The more useful lens is to read the alert as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar alerts have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized fda recalls advisory is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
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What Happened
Merit Medical Systems, Inc. has initiated a voluntary recall of the BioFlo DuraMax Catheter due to a design defect in the 16F dual-valved splittable sheath introducer. This defect may prevent the sheath from splitting as intended, potentially resulting in hemorrhage, foreign bodies, and procedure delays.
Which Products Are Affected
The affected products are BioFlo DuraMax Catheters with the following REF numbers: H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A, H965103028031/EU, H965103028041/A, H965103028041/EU, H965103028051/A, H965103028051/EU, H965103028061/A, H965103028061/EU, H965103028070/A, H965103028070/EU, H965103028080/A, H965103028080/EU, H965103028090/A, H965103028090/EU, H965103028161/A, H965103028181/A, H965103028191/A, H965103028191/EU, H965103028201/A, H965103028211/A, H965103028220/A, H965103028230/A, H965103028240/A, and H965103038181/A. The recall involves 47,153 units distributed worldwide, including nationwide in the United States to states such as 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 internationally to countries including Canada, Spain, and others. Specific code info includes UDI-DI and lot numbers as detailed in the recall notice.
What You Should Do
Consumers who have the affected BioFlo DuraMax Catheters should contact Merit Medical Systems, Inc. at their address, 1600 W Merit Pkwy, South Jordan, UT 84095-2416, for instructions on returns or refunds related to this recall.
Why This Matters
This Class I recall highlights a serious potential risk to patient safety due to the possibility of hemorrhage and other complications during medical procedures. It affects a large number of units distributed globally, emphasizing the need for immediate action to prevent adverse health outcomes.
Source
FDA recall notice with recall number Z-1579-2026.
Source: FDA Official Notice