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Terminated

Medtronic DxTerity Diagnostic Catheter, JL 4.0, REF DXT5JL40, marked with 6F color code on box.

FDA Recall Z-1479-2018 · Posted 2018-04-20

Recalling FirmMedtronic Vascular
Recall StatusTerminated
Product CodeDQO
Date Initiated2018-03-13
Date Terminated2021-05-07
Product Quantity855 units

Reason for Recall

The color coded French size indicator on the outer box may incorrectly reflect a 6 French size, rather than the correct 5 French size. The catheters inside the carton are the correct DXT5JL40 item, the inner pouch has correct 5F labeling, information and configuration details.

Firm Action

Medtronic initiated consignee communications on 13-Mar- 2018 to Risk Managers and Health Care Professionals. US notifications were sent via 2-Day UPS delivery. OUS communications were sent per locally approved methods. Consignees are asked to quarantine and return any unused potentially affected product to Medtronic.

Root Cause

Packaging

Distribution Pattern

US and AUSTRIA, Canada, Germany, ROMANIA, SLOVENIA,

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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