Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Medtronic DxTerity(TM) TRA 5F Recalled by Medtronic Vascular Due to Medtronic has determined that the French size indicator...
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 Medtronic Vascular directly.
Affected Products
Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35
Quantity: 250 units
Why Was This Recalled?
Medtronic has determined that the French size indicator on the inner pouch may incorrectly reflect a 6 French size, rather than the correct 5 French size. The catheters inside the pouch are the correct U5TRAN35 item, the outer carton has all the correct labeling, and all the other information and configuration details on both the carton and the pouch are correct.
Where Was This Sold?
This product was distributed to 7 states: CA, IA, NE, TN, TX, VA, WA
About Medtronic Vascular
Medtronic Vascular has 211 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report