BioFlo Dialysis Catheter recall in Canada: performance issue
In plain language
This recall involves BioFlo Dialysis Catheters with Endexo Technology sold in Canada. It's being recalled because a component, the sheath introducer, may not split as intended during use. This issue could lead to patient injury. Healthcare professionals should contact the manufacturer for more information.
What to do
- Discontinue use of the 16F dual-valved splittable sheath introducer immediately.
- Destroy the sheath introducer at the point of use.
- Contact Merit Medical Systems, Inc. for additional information.
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Affected products
BioFlo Dialysis Catheter With Endexo Technology
Model: H965103028031, H965103028041, H965103028051, H965103028061, H965103028070, H965103028080, H965103028090
Lot: All lots.
Why this matters
Hemorrhage, foreign bodies, and procedure delay
Do I have this product?
This recall only applies to specific products. Follow the steps below to check.
- 1
Check the product name
Make sure your product name matches one of the affected products listed above.
- 2
Check the lot number
Lot numbers identify specific production batches.
Affected lots: All lots.
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: H965103028031, H965103028041, H965103028051, H965103028061, H965103028070, H965103028080, H965103028090
If your product matches one or more of the details above, it may be affected by this recall.
If your product does not match these details, it is not affected by this recall.
When in doubt, always check the official notice.
Frequently Asked Questions
Why was this product recalled?
Hemorrhage, foreign bodies, and procedure delay
What should consumers do?
Discontinue use of the 16F dual-valved splittable sheath introducer immediately. Destroy the sheath introducer at the point of use. Contact Merit Medical Systems, Inc. for additional information.
Where was the product sold?
This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.
Is there a health risk?
Yes, there may be a health risk. Hemorrhage, foreign bodies, and procedure delay
When was this product recalled?
This product was recalled on February 19, 2026.
Is the BioFlo brand affected by this recall?
Yes, BioFlo products are affected by this recall. This recall involves BioFlo Dialysis Catheters with Endexo Technology sold in Canada. It's being recalled because a component, the sheath introducer, may not split as intended during use. This issue could lead to patient injury. Healthcare professionals should contact the manufacturer for more information.