FDAClass IIMarch 17, 2021

Medtronic 6F Launcher Guide Catheter 100cm EBU 3.75 recall: Sterility Concern

Medtronic 6F Launcher Guide Catheter 100cm EBU 3.75 Model Number: LA6EBU375

Why was Medtronic 6F Launcher Guide Catheter 100cm EBU 3.75 recalled?

Sterility may be compromised due to an unsealed pouch

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 Code: 220772561, 220772562

Product
Medtronic 6F Launcher Guide Catheter 100cm EBU 3.75 Model Number: LA6EBU375
Recalling firm
Medtronic Vascular
Quantity
10 Units
Distribution
Nationwide
Recall date
March 17, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls