The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-3258-2018·Announced 2018-10-03

Boston Scientific Recalls VALITUDE X4 CRT-P Pacemakers Due to Battery Depletion

Boston Scientific is recalling VALITUDE X4 CRT-P pacemakers because hydrogen-induced accelerated battery depletion may require early replacement.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a functional defect (battery depletion) that requires early replacement. Per the rubric, this falls under 'risk-of-harm products where injury has not yet been reported,' as no specific injuries or illnesses are cited in the source text.

Plain-English summary

Boston Scientific Corporation is recalling a subset of VALITUDE X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker) systems. The recall is due to an identified elevated potential for early pacemaker replacement caused by hydrogen-induced accelerated battery depletion.

The affected devices are the VALITUDE X4 (CRT-P) model U128. The source text does not specify the total number of units affected or the specific lot numbers involved.

Distribution of the recalled devices includes Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, and Wyoming.

Consumers and healthcare providers should contact Boston Scientific or their healthcare provider for instructions on how to proceed with the recall and potential replacement of the device.

The recalled product

Product
VALITUDE X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)
Manufacturer
Boston Scientific Corporation
Category
Medical Device — Pacemaker
Hazard

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 (1)

  • VALITUDE X4 (CRT-P) model U128

Distribution

Distributed in 48 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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