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Terminated

6F Taiga Guiding Catheter

FDA Recall Z-1207-2018 · Posted 2018-03-29

Recalling FirmMedtronic Inc
Recall StatusTerminated
Product CodeDQY
Date Initiated2017-09-26
Date Terminated2021-04-27
Product Quantity15,923

Reason for Recall

Complaints regarding 6F Taiga guide catheter tip detachment and/or tip splitting.

Firm Action

A recall notification was sent to all costumers in September 2017. Customers actions to be done: Identify and quarantine all unused affected products as listed in your inventory. Share notification with others who need to be aware where affected product may have potentially been transferred.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Japan

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K0834226F TAIGA GUIDING CATHETERMedtronic Vascular · 2009-02-06

Official Source

View FDA Recall →

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

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