ACCOLADE™ MRI DR L311Recalls & reported problems

Boston Scientific Corporation · Pacemaker · Class 3 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Quick summary

This Boston Scientific Accolade MRI DR pacemaker is implanted to regulate heartbeat. Reports mostly describe batteries draining early, noise sensed as heartbeats, and trouble communicating by radio. There are 7,044 reports, including 59 deaths and 4,139 injuries. Two recalls are open, both tied to pacemakers entering a safety mode because of high battery resistance. Reports rose to 1,479 in the last 12 months from 955 in the 12 months before.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports: 7,283
Deaths reported: 59
Injuries reported: 4,160
Recalls naming it: 2

Summary

The FDA's MAUDE database contains 7,283 adverse event reports that list this exact device (DI 00802526559228), received between Jul 16, 2016 and Sep 30, 2026 — classified as 59 deaths, 4,160 injuries, 3,064 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (2,020 reports).

2 FDA recall records name this device's identifier, 2 still open.

26 other recalls cover devices cleared under the same FDA submission (P150012); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Recalls naming this device

Aug 20, 2025Class IOpen, Classified
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Z-0095-2026 · Root cause: Other · Recall details · FDA record ↗
Dec 12, 2024Class IOpen, Classified
A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.
Z-0822-2025 · Root cause: Process design · Recall details · FDA record ↗

Most reported problems

Device problems

Premature Discharge of Battery2,020
Adverse Event Without Identified Device or Use Problem1,703
Over-Sensing991
High impedance685
Incorrect, Inadequate or Imprecise Result or Readings625
Signal Artifact/Noise575
Battery Problem539
Pacing Problem528

Patient problems

No Clinical Signs, Symptoms or Conditions4,106
Unspecified Infection1,416
No Known Impact Or Consequence To Patient521
Sepsis338
No Code Available292
No Consequences Or Impact To Patient193
Pocket Erosion185
Syncope/Fainting155

Recent adverse event reports

The 25 most recent of 7,283 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 30, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950541 ↗
MalfunctionSep 30, 2026Premature Discharge of Battery
It was reported that this pacemaker recorded a Code 1003, indicating the voltage is too low for the projected remaining capacity. Data analysis identified potential high impedance within the battery. Continued monitoring was recommended. This device remains in service. No adverse patient effects were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948442 ↗
MalfunctionSep 30, 2026Premature Discharge of Battery
It was reported that this pacemaker recorded a Code 1003, indicating the voltage is too low for the projected remaining capacity. Data analysis identified potential high impedance within the battery. Continued monitoring was recommended. This device remains in service. No adverse patient effects were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947235 ↗
InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that this pacemaker was explanted and replaced. No additional adverse patient effects were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946996 ↗
MalfunctionSep 29, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941390 ↗
MalfunctionSep 29, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941361 ↗
MalfunctionSep 29, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941359 ↗
MalfunctionSep 29, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940889 ↗
MalfunctionSep 29, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937702 ↗
InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient with this pacemaker experienced pocket erosion and infection. This pacemaker was subsequently explanted and has been returned. No additional adverse patient effects were reported.
Patient problems: Pocket Erosion; Unspecified Infection
MAUDE report 50937651 ↗
MalfunctionSep 29, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937127 ↗
MalfunctionSep 29, 2026Premature Discharge of Battery; Use of Device Problem; Interrogation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936902 ↗
MalfunctionSep 29, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936657 ↗
MalfunctionSep 29, 2026Signal Artifact/Noise; Over-Sensing
It was reported that this pacemaker and the right atrial (RA) lead exhibited oversensing of non-physiological and mild myopotential noise. This pacemaker recorded an inappropriate Atrial Tachy Response (ATR) episode due to the oversensing. Technical Services (TS) discussed performing isometrics to test for noise and impedance fluctuations. Also, TS provided reprogramming options. This pacemaker remains in service. No adverse patient effects were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935898 ↗
MalfunctionSep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Tachycardia
MAUDE report 50935653 ↗
MalfunctionSep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935569 ↗
MalfunctionSep 29, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935445 ↗
InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported that this pacemaker was explanted due to an unspecified reason. No additional adverse patient effects were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934997 ↗
MalfunctionSep 29, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934317 ↗
MalfunctionSep 29, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934127 ↗
MalfunctionSep 29, 2026Premature Discharge of Battery
It was reported that this pacemaker recorded a Code 1003, indicating the voltage is too low for the projected remaining capacity. Data analysis identified potential high impedance within the battery. Continued monitoring was recommended. This device remains in service. No adverse patient effects were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932362 ↗
MalfunctionSep 29, 2026Premature Discharge of Battery
It was reported that this pacemaker recorded a Code 1003, indicating the voltage is too low for the projected remaining capacity. A request was made to have data from this device analyzed. Data analysis identified potential high impedance within the battery. Continued monitoring was recommended. No adverse patient effects were reported. This device remains in service at this time.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931935 ↗
MalfunctionSep 29, 2026High impedance
It was reported that this pacemaker exhibited high out of range pacing impedance measurements on the right ventricular (RV) lead. Subsequently, this pacemaker was explanted due to normal battery depletion. This pacemaker was successfully replaced, and no additional adverse patient effects were reported. This pacemaker has not been returned for analysis.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931303 ↗
MalfunctionSep 29, 2026Premature Discharge of Battery
It was reported that this pacemaker recorded a Code 1003, indicating the voltage is too low for the projected remaining capacity. A request was made to have data from this device analyzed. Data analysis identified potential high impedance within the battery. Continued monitoring was recommended. This device remains in service. No adverse patient effects were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927809 ↗
InjurySep 28, 2026Premature Discharge of Battery; Use of Device Problem; Interrogation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926084 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P150012. One submission often covers many models, so check the product and lot details in each record.

Z-1770-2026 · Mar 19, 2026 · Open, Classified
Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac Re-Synchronization Therapy) labeled as: 1. ESSENTIO SR SL, Model Number L100; 2. ESSENTIO DR SL
Z-0084-2026 · Aug 20, 2025 · Open, Classified
ACCOLADE DR EL MRI (Model L331)
Z-0091-2026 · Aug 20, 2025 · Open, Classified
Model Number L231, PROPONENT DR EL MRI Pacemaker
Z-0081-2026 · Aug 20, 2025 · Open, Classified
ACCOLADE SR SL MRI (Model L310)
Z-0088-2026 · Aug 20, 2025 · Open, Classified
Model Number L210 PROPONENT SR SL Pacemaker
Z-0097-2026 · Aug 20, 2025 · Open, Classified
Model Number L131, ESSENTIO DR EL MRI Pacemaker
Z-0094-2026 · Aug 20, 2025 · Open, Classified
Model Number L110, ESSENTIO SR SL MRI Pacemaker
Z-0082-2026 · Aug 20, 2025 · Open, Classified
ACCOLADE DR SL MRI (Model L311)
Z-0089-2026 · Aug 20, 2025 · Open, Classified
Model Number L211 PROPONENT DR SL MRI Pacemaker
Z-0823-2025 · Dec 12, 2024 · Open, Classified
PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).
Z-0824-2025 · Dec 12, 2024 · Open, Classified
ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model Number L121), and EL MRI (Model Number L131)
Z-2000-2021 · Jun 3, 2021 · Open, Classified
Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331
Z-1999-2021 · Jun 3, 2021 · Open, Classified
Proponent pacemaker, Models: a) L200 b) L201 c) L209 d) L210 e) L211 f) L221 g) L231
Z-2017-2021 · Jun 3, 2021 · Open, Classified
VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)
Z-1998-2021 · Jun 3, 2021 · Open, Classified
Essentio pacemaker, Models: a) L100 b) L101 c) L110 d) L111 e) L121 f) L131

…and 11 more.

Device details

UDI-DI	`00802526559228`
Brand	ACCOLADE™ MRI DR
Model	L311
Company	Boston Scientific Corporation
Product code	LWP · Implantable pulse generator, pacemaker (non-CRT)
Class	Class 3
FDA submission	P150012
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Mar 19, 2026

Device type (GMDN): Dual-chamber implantable pacemaker, rate-responsive

A battery-powered, hermetically-sealed pulse generator, implanted beneath the skin of the chest in a surgically-created pocket, with pacing leads in or on two chambers of the heart (right atrium and ventricle). It is intended to stimulate the chambers of an abnormal heart, through electrical impulses, to beat in their natural sequence, and to adjust the rate of contraction to meet the body's increased need for blood flow due to activity. It contains one or more sensors to detect changes in the body (e.g., motion, breathing frequency) to indicate more oxygen is needed, and subsequently increases the pacing rate; it is not intended for defibrillation therapy.

Other Implantable pulse generator, pacemaker (non-CRT) devices

Assurity MRI™ PM2272
St. Jude Medical, Inc. · Implantable pulse generator, pacemaker (non-CRT)
1 recall264 deaths16,996 reports
ACCOLADE™ MRI EL DR L331
Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)
2 recalls22 deaths7,984 reports
Azure™ XT DR MRI SureScan™ W1DR01
Medtronic, Inc. · Implantable pulse generator, pacemaker (non-CRT)
187 deaths7,655 reports
Azure™ XT DR MRI SureScan™ W1DR01
Medtronic, Inc. · Implantable pulse generator, pacemaker (non-CRT)
107 deaths5,971 reports
ACCOLADE™ DR L301
Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)
2 recalls6 deaths2,513 reports
ACCOLADE™ EL DR L321
Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)
2 recalls2 deaths1,906 reports
ACUITY™ X4 Spiral S 4674
Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)
16 deaths1,975 reports
ESSENTIO™ MRI DR L111
Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)
2 recalls9 deaths1,790 reports

All Implantable pulse generator, pacemaker (non-CRT) devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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