Merit Medical Systems Recalls BioFlo Dialysis Catheter Components Due to Design Defect

Source: Health Canada · Canada

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Merit Medical Systems Inc. is recalling the 16F Dual-valved Splittable Sheath Introducer used with BioFlo Dialysis Catheters due to a defect that may cause hemorrhage or patient injury.

What this Health Canada recall tells you, and what most readers miss

This notice was issued by Health Canada on February 20, 2026 and geographically references Canada. 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 — Product & Food 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 a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly Health Canada detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized Health Canada recall 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 16F Dual-valved Splittable Sheath Introducer due to a design defect. The company has identified that the sheath introducer may not split as intended during use. This specific component is utilized in several finished medical devices, including the BioFlo DuraMax and BioFlo Dialysis Catheter with Endexo Technology.

Merit has received customer complaints regarding this issue, including reports of patient injury. If the sheath introducer fails to split correctly, it can lead to serious medical complications such as hemorrhage, the introduction of foreign bodies into the patient, and significant procedure delays.

Which Products Are Affected

The recall affects all lots of the BioFlo Dialysis Catheter With Endexo Technology. The following model/catalogue numbers are included in this action:

  • H965103028041
  • H965103028051
  • H965103028061
  • H965103028070
  • H965103028090
  • H965103028080
  • H965103028031

What You Should Do

Merit Medical Systems is requesting that all customers immediately discontinue the use of the 16F dual-valved splittable sheath introducer. The affected sheath introducers should be destroyed at the point of use.

Note that other products included within the catheter kits, aside from the specific sheath introducer, may continue to be used according to the manufacturer's instructions.

Why This Matters

This recall is significant because the defect poses a direct risk of physical injury and hemorrhage to patients undergoing dialysis catheter placement. The reported injuries and the potential for foreign bodies to remain in the patient necessitate immediate corrective action by medical facilities.

Source

Health Canada Recall Alert

Original source: Health Canada Official Notice ↗

All Product & Food Recalls →

Frequently Asked Questions

Common questions about this Health Canada recall.

What is this Health Canada recall about?
Merit Medical Systems Inc. is recalling the 16F Dual-valved Splittable Sheath Introducer used with BioFlo Dialysis Catheters due to a defect that may cause hemorrhage or patient injury.
Which agency issued this alert?
This alert was issued by Health Canada. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "high" severity. Take precautions and monitor for updates.
What area is affected?
This alert affects Canada. Check with Health Canada for the most current geographic scope.
Where can I find more Product & Food Recalls updates?
Browse the full Product & Food Recalls feed on Areazine at areazine.com/ca/recalls/ for the latest updates from Health Canada and other agencies.