FDAClass IINovember 19, 2014

Medtronic Launcher Coronary Guide Catheter recall

Medtronic Launcher Coronary Guide Catheter; MODEL: LA6JR40K

Why was Medtronic Launcher Coronary Guide Catheter 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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Number: 0007244836 MODEL: LA6JR40K

Product
Medtronic Launcher Coronary Guide Catheter; MODEL: LA6JR40K
Recalling firm
Medtronic Vascular
Quantity
11 devices
Distribution
US Distribution including the states of NC, IA, IL and KS.
Recall date
November 19, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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