The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0080-2018·Announced 2017-11-15

Boston Scientific Recalls Four Momentum X4 CRT-D Devices for Firmware Error

Boston Scientific is recalling four Momentum X4 CRT-D devices due to incorrect firmware configuration. The devices were distributed to medical facilities in Minnesota and Ohio.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity score when no specific hospitalization reports or serious injury data are provided in the source text.

Plain-English summary

Boston Scientific Corporation is recalling four units of the MOMENTUM X4 CRT-D, Model G138, Sterile. The recall is being conducted because the devices have an incorrect firmware configuration.

The affected devices, identified by serial numbers 377292, 377337, 377341, and 377347, were distributed to medical facilities located in Minnesota and Ohio. There was no foreign, government, or military distribution of these units.

This is a Class II recall, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Medical facilities should contact Boston Scientific for instructions on how to proceed with the affected devices.

The recalled product

Product
MOMENTUM X4 CRT-D, Model G138, Sterile.
Manufacturer
Boston Scientific Corporation
Category
Medical Device — Cardiac Rhythm Management
Hazard
Affected units
4

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Serial numbers 377292
  • 377337
  • 377341
  • and 377347

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 5 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

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