Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Vado Steerable Sheath 8.8F Recalled by Kalila Medical Due to Torn sheath liner material was detected at the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Kalila Medical directly.
Affected Products
Vado Steerable Sheath 8.8F, REF SS8FMU67, packaged in a lidded tray that is within a pouch which is inserted into a shelf carton, Sterile, Rx. The firm name on the label is Kalila Medical, Campbell, CA.
Quantity: 99 sheaths
Why Was This Recalled?
Torn sheath liner material was detected at the proximal end of the device during internal product testing which may be the result of damage incurred during the manufacturing process.
Where Was This Sold?
This product was distributed to 11 states: FL, GA, MD, MI, NJ, NY, OH, PA, SC, VA, DC
About Kalila Medical
Kalila Medical has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report