ACCOLADE™ MRI EL DR L331Recalls & reported problems

Boston Scientific Corporation · Pacemaker · Class 3 · Implant

Data updated Oct 16, 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 pacemaker is implanted to regulate heartbeat. Reports mostly describe batteries draining early, the device sensing noise as heartbeats, and low battery voltage warnings. There are 7,550 reports, including 22 deaths and 4,119 injuries. Two recalls are open, both tied to pacemakers entering a safety mode because of high battery resistance. Reports rose to 2,364 in the last 12 months from 1,144 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: 7,984
Deaths reported: 22
Injuries reported: 4,138
Recalls naming it: 2

Summary

The FDA's MAUDE database contains 7,984 adverse event reports that list this exact device (DI 00802526559266), received between Jul 12, 2016 and Sep 30, 2026 — classified as 22 deaths, 4,138 injuries, 3,824 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (2,847 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 16, 2026.

Reports received per month

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

Recalls naming this device

Aug 20, 2025Open, 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-0097-2026 · Root cause: Other · Recall details · FDA record ↗
Dec 12, 2024Open, 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 Battery2,847
Adverse Event Without Identified Device or Use Problem1,670
Over-Sensing1,189
High impedance711
Signal Artifact/Noise685
Pacing Problem611
Battery Problem478
Failure to Capture457

Patient problems

No Clinical Signs, Symptoms or Conditions5,029
Unspecified Infection1,408
No Known Impact Or Consequence To Patient405
Sepsis292
No Code Available231
No Consequences Or Impact To Patient224
Syncope/Fainting156
Asystole121

Recent adverse event reports

The 25 most recent of 7,984 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 50950013 ↗
MalfunctionSep 30, 2026Use of Device Problem; Data Problem; Interrogation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949567 ↗
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 50949406 ↗
MalfunctionSep 30, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948705 ↗
MalfunctionSep 30, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947881 ↗
InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that this pacemaker was part of a system revision due to infection. There were no additional adverse patient effects reported. The pacemaker was explanted.
Patient problems: Unspecified Infection
MAUDE report 50947546 ↗
MalfunctionSep 30, 2026Premature Discharge of Battery; High impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941473 ↗
MalfunctionSep 29, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940890 ↗
MalfunctionSep 29, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938658 ↗
MalfunctionSep 29, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938651 ↗
MalfunctionSep 29, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938649 ↗
MalfunctionSep 29, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938514 ↗
MalfunctionSep 29, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938249 ↗
MalfunctionSep 29, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937968 ↗
MalfunctionSep 29, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937128 ↗
MalfunctionSep 29, 2026Use of Device Problem; Interrogation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937082 ↗
MalfunctionSep 29, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937081 ↗
MalfunctionSep 29, 2026Use of Device Problem; Data Problem; Interrogation Problem
It was reported that this pacemaker exhibited a Remote Monitoring Disabled (RMD) alert indicating limited battery capacity, with an explant indicator date on (b)(6) 2000, following a recent medical procedure. Technical Services (TS) reviewed the available device information and submitted the event for engineering evaluation. Engineering analysis determined that the event was highly likely a false positive RMD trigger caused by magnet application during a loaded battery measurement, as the battery had not yet reached the threshold of its elective replacement indicator (ERI) capacity. It was recommended that the device be updated with the newest software to restore full telemetry functionality. No adverse patient effects were reported. This pacemaker remains in service.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936656 ↗
MalfunctionSep 29, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935710 ↗
MalfunctionSep 29, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934993 ↗
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 50933677 ↗
MalfunctionSep 29, 2026Interrogation Problem
It was reported that the patient with this pacemaker was being seen in the clinic. While in the clinic, a message was displayed indicating that radio frequency (RF) telemetry was disabled. Technical Services (TS) reviewed the data and discussed the device had the most recent software and suspected that when the software was downloaded, the battery voltage was low enough that it disabled RF in the device. A clinician confirmed RF was disabled. TS recommended device replacement. No adverse patient effects were reported. This pacemaker remains in service.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931991 ↗
InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported that this pacemaker was part of the system revision due to infection. No adverse patient effects were reported. The pacemaker was explanted.
Patient problems: Unspecified Infection
MAUDE report 50930169 ↗
MalfunctionSep 28, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925871 ↗
MalfunctionSep 28, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925870 ↗

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-0091-2026 · Aug 20, 2025 · Open, Classified
Model Number L231, PROPONENT DR EL MRI Pacemaker
Z-0088-2026 · Aug 20, 2025 · Open, Classified
Model Number L210 PROPONENT SR SL Pacemaker
Z-0095-2026 · Aug 20, 2025 · Open, Classified
Model Number L111, ESSENTIO DR SL MRI Pacemaker
Z-0089-2026 · Aug 20, 2025 · Open, Classified
Model Number L211 PROPONENT DR SL MRI Pacemaker
Z-0082-2026 · Aug 20, 2025 · Open, Classified
ACCOLADE DR SL MRI (Model L311)
Z-0081-2026 · Aug 20, 2025 · Open, Classified
ACCOLADE SR SL MRI (Model L310)
Z-0094-2026 · Aug 20, 2025 · Open, Classified
Model Number L110, ESSENTIO SR SL MRI Pacemaker
Z-0084-2026 · Aug 20, 2025 · Open, Classified
ACCOLADE DR EL MRI (Model L331)
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-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
Z-2000-2021 · Jun 3, 2021 · Open, Classified
Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331

…and 11 more.

Device details

UDI-DI	`00802526559266`
Brand	ACCOLADE™ MRI EL DR
Model	L331
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
Azure™ XT DR MRI SureScan™ W1DR01
Medtronic, Inc. · Implantable pulse generator, pacemaker (non-CRT)
187 deaths7,655 reports
ACCOLADE™ MRI DR L311
Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)
2 recalls59 deaths7,283 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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