Z-1207-2018Class I

6F Taiga Guiding Catheter

Name: Z-1207-2018 6F Taiga Guiding Catheter
Creator: Medtronic Inc
Published: 2017-09-26
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2017-09-26 / Terminated / root cause: manufacturing process

FDA source

Medtronic Inc began a recall of 6F Taiga Guiding Catheter on 2017-09-26. FDA classified it as Class I and gives the reason as "Complaints regarding 6F Taiga guide catheter tip detachment and/or tip splitting". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1207-2018
Classification: Class I
Status: Terminated
Initiated: 2017-09-26
Posted: 2018-03-29
Terminated: 2021-04-27
Recalling firm: Medtronic, Inc.
Product: 6F Taiga Guiding Catheter
Product code: DQY Catheter, Percutaneous
Reason for recall: Complaints regarding 6F Taiga guide catheter tip detachment and/or tip splitting.
Root cause tag: manufacturing process
FDA 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 in commerce: 15,923
Distribution: Japan
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Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1207-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1207-2018	Class I	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-29

Product code DQY

K083422Class II6F Taiga Guiding CatheterMedtronic Vascular / cleared 2009-02-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)