Medtronic Inc: 6F Taiga Guiding Catheter

Recall number

Z-1207-2018

Recalling firm

Medtronic Inc

Product

6F Taiga Guiding Catheter

Status

Terminated

Initiated

2017-09-26

Posted

2018-03-29

Terminated

2021-04-27

Reason

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

Root cause

Nonconforming Material/Component

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.

Quantity

15,923

Distribution

Japan

Lot, serial or model codes

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510(k) numbers

["K083422"]

PMA numbers

not on file

Product code

DQY

Firm FEI

3001504994

Firm city

Minneapolis

Firm state

MN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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