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6F Taiga Guiding Catheter recallZ-1207-2018 · Medtronic Inc · initiated Sep 26, 2017

Class I Terminated All recalls posted in March 2018

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medtronic Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Nonconforming Material/Component

What the company is doing

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.

Recall details

Recall number
Z-1207-2018
Recall class
Class I (most serious)
Status
Terminated
Initiated by the company
Sep 26, 2017
Posted by the FDA
Mar 29, 2018
Recalling firm
Medtronic Inc
Quantity
15,923
Product code
DQY
FDA submissions
K083422
Distribution
Japan

Product description

6F Taiga Guiding Catheter

Code information (models, lots, serial numbers)

Show the full code information (10k characters)

Lot/Serial Number's: 0008104881, 0008185945, 0008448845, 0008498609, 0008591678, 0008603130, 0008128237, 0008185937, 0008359341, 0008381347, 0008520748, 0008572204, 0008584614, 00 887489, 0008132544, 0008143685, 0008153935, 0008176874, 0008181991, 0008189749, 0008195422, 0008220305, 0008399842, 0008411526, 0008479077, 0008498645, 0008510155, 0008560305, 0008588040, 0008609897, 0008614083, 0008092512, 0008117850, 0008171020,  0008173080, 0008185946, 0008195426, 0008250618, 0008374572, 0008399835, 0008411525, 0008510141, 0008584625, 0008589932, 0008609899, 0008084699, 0008092511, 0008143683, 0008156792, 0008169119, 0008191347, 0008448842, 0008479041, 0008498608,  0008527623, 0008090683, 0008121917, 0008128241, 0008148608, 0008169116, 0008191339, 0008401589, 0008503947, 0008510133, 0008580930, 0008580935, 0008580939, 0008589915, 0008121924, 0008132534, 0008150901, 0008401588, 0008418561, 0008441398,  0008448854, 0008503956, 0008588042, 0008603140, 0008614065, 0008087481, 0008090682, 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Other devices under the same FDA submission

3 devices cleared under K083422 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page