Boston Scientific Recalls ESSENTIO EL DR Pacemakers Due to Sensor Issues
Boston Scientific is recalling ESSENTIO EL DR pacemakers due to reports of intermittent over-sensing of the Minute Ventilation sensor signal.
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 (sensor over-sensing) that poses a risk of harm, but the source text does not report specific injuries, hospitalizations, or fatalities, nor does it classify the recall as FDA Class I.
Plain-English summary
Boston Scientific Corporation is recalling ESSENTIO EL DR pacemakers (Model L121). The recall is being conducted because the company has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal in certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems.
The affected devices were distributed in all 50 U.S. states, Puerto Rico, and worldwide. The specific quantity of units affected is not stated in the source text.
Consumers with these devices should contact their healthcare provider or Boston Scientific for further instructions regarding the recall and potential replacement or repair.
The recalled product
- Product
- ESSENTIO EL DR 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)
- Model L121
Distribution
Part of a larger recall action
This product is one of 24 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 24 products in this recall →Related recalls
Same manufacturer · Boston Scientific Corporation
See all →- SevereBoston Scientific Recalls Imager II Angiographic Catheters Due to Tip Fracture Risk
FDA (Devices) · 2026-09-30
- ModerateBoston Scientific StoneSmart Connect Console Power Adapter Recall
FDA (Devices) · 2026-09-23
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
Same hazard · sensor malfunction
See all →- ModeratePhotera 600 Phototherapy Device UV Sensor Calibration Error
FDA (Devices) · 2026-07-22
- ModeratePhotera 600 3-D phototherapy device UV sensor calibration error recall
FDA (Devices) · 2026-07-22
- SevereiLet Bionic Pancreas Software Versions Recalled for Delayed CGM Readings
FDA (Devices) · 2026-05-06
- SevereAbiomed Impella RP with SmartAssist recalled as Class I
FDA (Devices) · 2026-03-11
- SevereAbiomed Impella RP recalled as Class I over sensor malfunction risk
FDA (Devices) · 2026-03-11
Similar recalls
- SevereESSENTIO DR Pacemakers May Malfunction Due to Battery Impedance Issue
FDA (Devices) · 2025-01-22
- SevereBoston Scientific Recalls ESSENTIO Pacemakers Due to Battery Depletion
FDA (Devices) · 2018-10-03
- SevereVITALIO DR EL Pacemakers Recalled Due to Battery-Related Device Resets
FDA (Devices) · 2021-07-21
- SevereBoston Scientific ADVANTIO DR EL Pacemakers Recalled for Battery Malfunction
FDA (Devices) · 2021-07-21
- CriticalESSENTIO extended life MRI pacemakers recalled for Safety Mode software update
FDA (Devices) · 2025-10-22
- CriticalESSENTIO dual chamber extended life pacemakers recalled for software update
FDA (Devices) · 2025-10-22