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.
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.
The French size indicator on the inner pouch might incorrectly show a 6 French size instead of the correct 5 French size. This could lead to using catheters that are too large for the intended medical procedure, potentially causing complications. However, the catheters themselves are correct and the outer packaging has proper labeling.
Healthcare professionals using the specific catheter model and lot numbers are most likely affected. Patients receiving procedures with these catheters may also be impacted if improper sizing occurs.
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.
Verify the UDI/GTIN number 20643169738717 and lot number 60068186 on the carton.
No, the catheters inside the pouch are correct. The issue is only with the French size indicator on the inner pouch.
Healthcare providers should check the UDI/GTIN and lot number on the carton to confirm if the catheter is affected.
The recall record does not mention any remedy or fix for this specific issue.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-3253-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-3253-2018 from Medtronic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
