Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Sarns Malleable Dual-stage Venous Return Cannulae Recalled by Terumo Cardiovascular Systems Corporation Due to During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS)...
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 Terumo Cardiovascular Systems Corporation directly.
Affected Products
Sarns Malleable Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2" connector, 15" (38 cm) long, with X Coating The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
Why Was This Recalled?
During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stage Venous Return Cannulae.
Where Was This Sold?
This product was distributed to 15 states: CA, CT, FL, GA, IL, IN, LA, MI, MN, MO, NY, NC, PA, TN, TX
About Terumo Cardiovascular Systems Corporation
Terumo Cardiovascular Systems Corporation has 204 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report