Agency classClass IIOur severity:Severe FDA (Devices)·Z-3255-2018·Announced 2018-10-03

Boston Scientific Recalls ESSENTIO Pacemakers Due to Battery Depletion

Boston Scientific is recalling ESSENTIO pacemakers and CRT-P systems due to an elevated potential for early replacement caused by hydrogen-induced accelerated battery depletion.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is Class II, and the hazard involves accelerated battery depletion in a life-sustaining medical device, which poses a significant risk of harm requiring early replacement.

Plain-English summary

Boston Scientific Corporation is recalling specific models of ESSENTIO pacemakers and CRT-P systems. The affected devices include the ESSENTIO SR (L100), ESSENTIO DR (L101), ESSENTIO MRI SR (L110), ESSENTIO MRI DR (L111), ESSENTIO EL DR (L121), and ESSENTIO MRI EL DR (L131) models.

The recall is being conducted because Boston Scientific identified a subset of these active systems with an elevated potential for early pacemaker replacement. This issue is attributed to hydrogen-induced accelerated battery depletion.

The affected devices were distributed in 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. Patients with these devices should contact their healthcare provider for evaluation and potential replacement.

The recalled product

Product: ESSENTIO Pacemaker
Manufacturer: Boston Scientific Corporation
Category: Medical Device — Pacemaker
Hazard: battery-depletion
device-failure

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 (6)

ESSENTIO SR model L100
ESSENTIO DR model L101
ESSENTIO MRI SR model L110
ESSENTIO MRI DR model L111
ESSENTIO EL DR model L121
and ESSENTIO MRI EL DR model L131

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 →

Same manufacturer · Boston Scientific Corporation

See all →

Severe
Boston Scientific Recalls Imager II Angiographic Catheters Due to Tip Fracture Risk
FDA (Devices) · 2026-09-30
Moderate
Boston Scientific StoneSmart Connect Console Power Adapter Recall
FDA (Devices) · 2026-09-23
High
Boston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
High
Boston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
High
Boston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09

Same hazard · battery depletion