FDAClass IINovember 15, 2017

Momentum X4 Crt-d recall

MOMENTUM X4 CRT-D, Model G138, Sterile.

Why was Momentum X4 Crt-d recalled?

The devices have an incorrect firmware configuration.

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?

Serial numbers 377292, 377337, 377341, and 377347

Product
MOMENTUM X4 CRT-D, Model G138, Sterile.
Recalling firm
Boston Scientific Corporation
Quantity
4 devices
Distribution
The devices were distributed to medical facilities located in MN and OH. There was no foreign/government/military distribution.
Recall date
November 15, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls