Lower riskMedical device recall · FDA · Published August 16, 2018
Medtronic DxTerity TRA 5F Catheter Recall: Incorrect French Size Labeling
Medtronic recalls DxTerity TRA 5F diagnostic catheters with potential incorrect French size labeling that could lead to improper sizing. Affected units have specific UDI/GTIN and lot numbers.
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.
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📍Recalling firmMedtronic Vascular35-37A Cherry Hill Drive · Danvers, MA 01923-2565
✎ GovInfoNow plain-language explainer
Medtronic is recalling certain DxTerity TRA 5F diagnostic catheters due to a possible error in the French size indicator on the inner pouch. This could lead to incorrect sizing during medical procedures, though the catheters themselves are correct and the outer packaging is properly labeled. Read more at govinfonow.com/recall/70017-medtronic-dxterity-tra-5f-catheter-recall-incorrect-french-size-labeling.
“Medtronic DxTerity TRA 5F Catheter Recall: Incorrect French Size Labeling.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70017-medtronic-dxterity-tra-5f-catheter-recall-incorrect-french-size-labeling. Based on FDA recall #Z-3253-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3253-2018%22&limit=1).
The FDA announced on Aug. 16, 2018, that Medtronic Vascular is recalling its DxTerity(TM) TRA 5F Diagnostic Catheter (REF U5TRAN35). The hazard involves a French size indicator on the inner pouch that may incorrectly reflect a 6 French size instead of the correct 5 French size.
How to tell if you have it
Brand: Medtronic
Product: DxTerity(TM) TRA 5F, Diagnostic Catheter
REF: U5TRAN35
UPC: 20643169738717
Lot Number: 60068186
The hazard
The inner pouch's French size indicator may incorrectly reflect a 6 French size, rather than the correct 5 French size. The catheters inside are the correct U5TRAN35 item, and the outer carton has all the correct labeling.
Context
GovInfoNow's records show Medtronic Vascular has 5 other recalls on record since March 13, 2018. Other recent recalls of similar products include Medtronic Vascular Angiographic Guidewire Component Recall (May 4, 2021), Medtronic 6F Launcher Guide Catheter Recall (Jan. 15, 2021), and Medtronic Vascular Rashkind Balloon Septostomy Catheter Recall (Aug. 25, 2020). Other recent recalls of similar products include Medline Medical Procedure Kits: Catheter Issues Recalled (May 4, 2026) and Medline Tonsil Pack Catheter Kits: Catheter Issues Recalled (May 4, 2026).
How to tell if you have this one
Check for the UDI/GTIN number 20643169738717 and lot number 60068186 on the carton. The catheter model is Medtronic DxTerity TRA 5F with reference number U5TRAN35.
Brand
Medtronic
Product
Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the UDI/GTIN number 20643169738717 and lot number 60068186 on the carton.
Where it went and when
Where it was distributed
Distributed in 7 states.
Listed by the agency
Not listed
FDA distribution: “CA, IA, NE, TN, TX, VA, WA, Jamaica, New Zealand, Thailand” States read from FDA’s own wording; “not listed” means the notice does not name it.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-3253-2018 (August 16, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3253-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.