Agency classClass IOur severity:Severe FDA (Devices)·Z-0824-2025·Announced 2025-01-22

ESSENTIO DR Pacemakers May Malfunction Due to Battery Impedance Issue

Boston Scientific is recalling certain ESSENTIO DR Pacemakers manufactured before September 2018 due to latent battery impedance that may cause Safety Mode malfunction during normal operations.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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: This is an FDA Class I recall, the most serious FDA classification. Per the severity rubric, FDA Class I recalls must score at minimum 4 regardless of reported illnesses.

Plain-English summary

Boston Scientific Corporation has issued a recall of certain ESSENTIO DR Pacemaker models (L101, L111, L121, and L131) manufactured before September 2018. These devices contain latent high battery impedance that may cause them to initiate Safety Mode unexpectedly during normal operations such as telemetry or other higher-power functions, potentially affecting pacing therapy delivery.

The recall affects approximately 59,937 units in the United States, including Puerto Rico and the U.S. Virgin Islands, with an additional 96,792 units distributed internationally to Guam and the Northern Mariana Islands.

Patients should consult their healthcare provider regarding this recall. Healthcare providers can identify affected devices using the model numbers and serial numbers provided.

The recalled product

Product: ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model Number L121), and EL MRI (Model Number L131)
Manufacturer: Boston Scientific Corporation
Category: Medical Device — Pacemaker
Hazard: battery-impedance
device-malfunction

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 (3)

L101 - UDI-DI: 00802526558924 and 00802526558931
00802526576317
00802526576812

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 6 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 6 products in this recall →

Same manufacturer · Boston Scientific Corporation

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Same hazard · battery impedance