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Medtronic Launcher Coronary Guide Catheter recallZ-0205-2015 · Medtronic Vascular · initiated Oct 13, 2014

Class II Terminated All recalls posted in November 2014

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 Vascular 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

Two reports have been received on the 6F launcher Guide Catheter lot (Model Number LA6JR40K; lot No 0007244836} for incorrect usable length of the Guide Catheter. It was reported that the catheters had a usable length of 90 cm instead of 55 cm, which was specified on the packaging label. Usable length is defined as the total length of catheter shaft from the distal end of the strain relief to the

FDA root cause category: Process control

What the company is doing

Beginning October 13, 2014, Medtronic field representatives will being hand delivery of the customer communication to affected customers, notifying them of the issue, and requesting return of unaffected product. Customers will be asked to sign a certificate confirming they have received the notification and have taken the requested action. 1. Identify and quarantine all listed, unused product in your inventory. 2. Return all listed product in your inventory to Medtronic. Contact Customer Service at 888-283-7868 to initiate a product return and credit. Your Medtronic sales representative can assist you in the return of this product as necessary. 3. Complete the attached Customer Confirmation Certificate and email it to [email protected] or fax it to Medtronic at 651-367-0612 to the attention of Customer Focused Quality.

Recall details

Recall number
Z-0205-2015
Recall class
Class II
Status
Terminated
Initiated by the company
Oct 13, 2014
Posted by the FDA
Nov 13, 2014
Recalling firm
Medtronic Vascular
Quantity
11 devices
Product code
DQY
FDA submissions
K021256
Distribution
US Distribution including the states of NC, IA, IL and KS.

Product description

Medtronic Launcher Coronary Guide Catheter; MODEL: LA6JR40K

Code information (models, lots, serial numbers)

Lot Number: 0007244836 MODEL: LA6JR40K

Other devices under the same FDA submission

50 devices cleared under K021256 — 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