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Terminated

Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35

FDA Recall Z-3253-2018 · Posted None

Recalling FirmMedtronic Vascular
Recall StatusTerminated
Product CodeDQO
Date Initiated2018-08-16
Date Terminated2021-05-07
Product Quantity250 units

Reason for Recall

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.

Firm Action

Medtronic initiated consignee communications on 16-Aug-2018 to Risk Managers and Health Care Professionals. US notifications were sent via 2-Day UPS delivery. Consignees are asked to quarantine and return any unused potentially affected product to Medtronic.

Root Cause

Error in labeling

Distribution Pattern

CA, IA, NE, TN, TX, VA, WA, Jamaica, New Zealand, Thailand

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K161287DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-PakMedtronic Vascular · 2016-08-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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