Recall of BioFlo DuraMax Catheters Due to Design Defect
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
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 recall 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 consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
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.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (2,001 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to April 8, 2026.
Frequently Asked Questions
Common questions about this FDA recall.