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U.S. Department of Health and Human Services

Class 1 Device Recall 6F Taiga Guiding Catheter

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 Class 1 Device Recall 6F Taiga Guiding Cathetersee related information
Date Initiated by FirmSeptember 26, 2017
Date PostedMarch 29, 2018
Recall Status1 Terminated 3 on April 27, 2021
Recall NumberZ-1207-2018
Recall Event ID 79449
510(K)NumberK083422 
Product Classification Catheter, percutaneous - Product Code DQY
Product6F Taiga Guiding Catheter
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Recalling Firm/
Manufacturer		 Medtronic Inc
710 Medtronic Pkwy
NE Mailstop LS245
Minneapolis MN 55432-5603
For Additional Information Contact
763-514-4000
Manufacturer Reason
for Recall		Complaints regarding 6F Taiga guide catheter tip detachment and/or tip splitting.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionA 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 Commerce15,923
DistributionJapan
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DQY
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