Pacemaker & Defibrillator Recalls

Pacemakers and defibrillators keep hearts beating safely, so a problem with a battery, software or lead can be serious. Boston Scientific has recalled certain ACCOLADE pacemakers over a battery-related Safety Mode and warned that certain RELIANCE defibrillator leads can calcify and weaken shocks. Most of these actions are corrections, not removals. A pacemaker lawyer looks at what the device recorded and what happened to the patient.

Generators, leads and software are different parts

A pacemaker keeps the heart from beating too slowly. An implantable cardioverter defibrillator (ICD) watches for dangerous fast rhythms and can deliver a shock to restore a normal beat. Both systems have:

• A generator: the battery and electronics, implanted under the skin
• Leads: wires that run to the heart
• Software or firmware inside the generator
• Monitoring: home transmitters and clinic programmers that read the device

A recall usually involves one part, not the whole system. A battery issue in a pacemaker and a lead issue in a defibrillator are different problems with different consequences and remedies.

ACCOLADE pacemaker recalls

Boston Scientific recalled certain ACCOLADE-family pacemakers and cardiac resynchronization pacemakers (CRT-Ps) because of a manufacturing issue that could make the device enter Safety Mode. Safety Mode starts after three battery-related power-on resets within 48 hours. Once triggered it can't be reversed, the device may provide only limited (unipolar) sensing and pacing, and early replacement is needed. The FDA notice says interruption of pacing can lead to serious injury or death, lists ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2, VISIONIST and VALITUDE models, and reports 832 injuries1.

Follow-up actions came in August 2025 and again in 2026. The 2026 correction expanded to all ACCOLADE CRT-P and DR-EL devices because high battery impedance could disable wireless telemetry and lead to early replacement. The fix is a software update, called Brady SMR6, installed when a clinic checks the device with an updated programmer. As of March 18, 2026, Boston Scientific had reported four deaths and 2,557 serious injuries associated with the issue2.

ACCOLADE actions

1. Dec. 2024

   Initial recall (No. 95969) over Safety Mode risk2.

2. Aug. 2025

   Follow-up recall (No. 97467).

3. Mar. 19, 2026

   Correction letter: upgrade programmers and devices to Brady SMR6.

A correction updates software at a clinic visit. It doesn't by itself mean the pacemaker must be removed.

RELIANCE defibrillator lead alert

Separately, Boston Scientific warned that certain ENDOTAK RELIANCE defibrillation leads with ePTFE-coated coils can calcify. The calcium can insulate the coil so that the ICD can't deliver its full shock energy, which may fail to restore a normal rhythm during cardiac arrest. The most common harm is early lead replacement; the most serious is death or the need for resuscitation. As of July 24, 2025, Boston Scientific had reported 386 serious injuries and 16 deaths3.

This is also a correction, not a removal. The company recommended continued follow-up, including remote monitoring, watching a measurement called low-voltage shock impedance, and replacing leads with impedance over 150 ohms3. Lead replacement or extraction is a significant procedure that cardiologists decide case by case.

Two different issues

ACCOLADE

Pacemaker battery behavior; fixed with software at a clinic visit2.

RELIANCE

Defibrillator lead coil calcification; monitored, and leads replaced when readings cross a threshold3.

Common thread

Both are corrections. Neither automatically requires surgery.

What interrogation records show

Every time a clinic checks a pacemaker or ICD, it creates an interrogation report. Remote monitoring sends similar data from home. These records can show battery status, alerts, Safety Mode events, lead impedance and whether the device paced or shocked. In a claim, they're often the most important evidence of what the device did and when.

Who may have a pacemaker or defibrillator claim

• A device that entered Safety Mode or needed early replacement
• A defibrillator that failed to shock, or shocked when it shouldn't have, with records showing it
• Emergency care, fainting or injury tied to a pacing interruption
• Lead replacement or extraction surgery
• A recalled generator or lead confirmed by model and serial number

Being on a recall list is not an injury by itself. A review looks for a device event and the harm that followed.

Who may be responsible

An investigation may look at the maker of the specific generator or lead, based on the recall, the device data and what happened. Many cardiac devices go through premarket approval, which raises federal pre-emption questions a lawyer must evaluate.

Filing deadlines for pacemaker and defibrillator lawsuits

Deadlines depend on your state and on when you learned of the problem and its possible cause. Examples:

• Arizona: generally two years for personal injury and wrongful death4.
• California: two years for injury to or death of a person caused by another's wrongful act or neglect5.
• New York: three years for personal injury6, with a separate rule that runs from discovery for injuries caused by the latent effects of exposure to a substance in the body7.
• Texas: two years for personal injury and wrongful death8, and most product liability claims must be brought within 15 years of the product's sale9.

When the clock starts can depend on when a person knew, or should have known, about the injury and its possible cause. Rules for minors, wrongful death and claims against public hospitals can differ. A device that was part of an earlier settlement can raise its own questions. Ask a medical device attorney to check the rules for your state early, before records are lost.

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Records that help a pacemaker or defibrillator review

Records worth gathering

Device

• Device ID cards for the generator and leads
• Implant dates
• Model and serial numbers

Data

• Interrogation reports
• Remote monitoring alerts
• Advisory letters from the clinic or manufacturer

Care

• Emergency room records
• Replacement or extraction reports

What happens after you contact CBW Law

How a review works

1. Tell us what happened

   Share what you remember about the device, the problem and the treatment that followed. You do not need every record first.

2. We identify the device

   We work to confirm the maker, model and lot or serial number, and whether any recall or safety notice covers it.

3. We gather records

   With your permission, we request operative reports, imaging, device data and other records from your providers.

4. We explain what we see

   We tell you what the records show, what questions remain and what options may be open, including deadlines.

A recall notice for a heart device is not proof of a claim. What the device recorded and what happened to the patient come first.

Plain English

Medical, Health & Insurance

Terms you may see in a heart device case.

Devices

CRT-P

A cardiac resynchronization pacemaker that paces both lower chambers of the heart.

ICD

An implantable cardioverter defibrillator that can shock the heart back to a normal rhythm.

Device data

Interrogation

Reading data from an implanted device with a programmer.

Impedance

Electrical resistance in a lead or battery; rising values can signal a problem3.

Procedures

Generator change

Surgery to replace the battery unit.

Lead extraction

Removing leads from the heart, a complex procedure.

Questions

Pacemaker and defibrillator lawsuit questions

Short answers to the questions people ask first.

Does a pacemaker recall mean my device has to come out?

Not necessarily. The ACCOLADE and RELIANCE actions are corrections handled through software and monitoring. Your cardiologist decides about replacement.

What is Safety Mode?

A backup state that turns on after certain battery failures. In affected ACCOLADE devices it can't be reversed and limits pacing, so early replacement is needed.

What is the RELIANCE lead issue?

Calcium buildup on certain coated defibrillator coils can stop the ICD from delivering a full shock.

Do I need a pacemaker lawyer if my device was replaced early?

If you needed early replacement or were hurt, a pacemaker lawyer can review the device data and your records.

Should I change my device settings?

No. Only your cardiology team should change settings.

What are interrogation reports?

Readouts from the device that show battery, alerts, lead readings and therapy delivered.

Can I sue over a PMA-approved heart device?

Federal pre-emption limits some claims, but not all. A defibrillator attorney has to review the specific facts.

How long do I have to file a pacemaker or defibrillator lawsuit?

It depends on your state and on when you learned of the problem and its possible cause.

How do I check if my device is affected?

Boston Scientific offers a model and serial number lookup, and your clinic can check.

What does it cost to contact CBW Law?

Telling us your story costs nothing, and contacting us does not create an attorney-client relationship.

Tell Us Your Story

If your pacemaker or defibrillator failed or needed early replacement, a pacemaker recall attorney can review what happened.

Tell us what happened. CBW Law will review your information and explain what we see. Submitting information does not establish an attorney-client relationship or guarantee representation.

Tell Us Your Story →Call (800) 476-2416

This page is general information about pacemaker and defibrillator recalls. It is not legal or medical advice and does not create an attorney-client relationship. A recall or correction does not, by itself, establish that a device caused an injury or that anyone is legally responsible. Never change device settings or seek removal without your cardiologist's advice. Laws and deadlines differ by state, and no outcome can be promised.