Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
St. Jude Medical Recalled by St Jude Medical Due to St. Jude Medical is performing a voluntary recall...
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 St Jude Medical directly.
Affected Products
St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353
Quantity: 26
Why Was This Recalled?
St. Jude Medical is performing a voluntary recall of batch 4671318, model number 401353 of the Response Fixed Curve DECA 6F 65cm CSL 2/8 Catheter. Specifically, the firm has identified that every device packaged within batch 4671318 contains the incorrect catheter (Supreme FC QUAD 5F catheter) within the packaging. To date, no serious injuries have occurred as a result of this issue
Where Was This Sold?
This product was distributed to 6 states: CA, GA, NJ, NY, OR, PA
About St Jude Medical
St Jude Medical has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report