Boston Scientific Pacemaker claims

The recall issued in December 2024 affects a number of Boston Scientific pacemaker and CRT-P models manufactured before September 2018. These include the ACCOLADE™, PROPONENT™, ESSENTIO™, ALTRUA™ 2, VISIONIST™ and VALITUDE™ devices. They were used to treat patients with slow or irregular heart rhythms (bradyarrhythmia) or ventricular desynchrony. If you’re unsure whether your device is affected, we can help you find out.

Safety Mode is intended as a fallback setting in pacemakers, but due to battery issues, affected Boston Scientific devices may enter this mode prematurely, especially when the battery has less than four years of estimated life remaining. When this happens, patients may experience critical symptoms. In some cases, immediate surgical replacement of the pacemaker is required.

Claims are being pursued under the Consumer Protection Act 1987. This means you don’t need to prove that Boston Scientific was negligent in the traditional sense – only that the device was defective and that the defect caused your harm.

The legal grounds being investigated include: the acknowledged manufacturing defect causing devices to enter Safety Mode prematurely; failure to adequately warn patients about the risks or to ensure appropriate monitoring once the issue became known; and manufacturing inconsistencies linked to high battery impedance that should have been identified and addressed sooner.

A group action – sometimes called a group litigation order – brings together a number of people who have been harmed by the same product or issue. By joining forces, claimants benefit from shared legal costs, a coordinated strategy, and pooled medical evidence, which can strengthen the overall case.

Our group actions team is experienced in managing complex multi-claimant cases and will coordinate every aspect of the legal process on your behalf. If sufficient numbers of affected patients come forward, we’ll progress with a formal group legal action.

Product liability claims – particularly those involving group actions and recalled medical devices – can take a number of years to resolve. The timeline depends on factors including the complexity of the medical evidence, the number of claimants involved, and whether the case proceeds to court or reaches a settlement.

We’ll keep you updated throughout the process and explain clearly what to expect at each stage. Our focus is on achieving the best possible outcome for you, and we’ll not rush the process at the expense of your claim’s strength.

You don’t need to gather all the evidence yourself – that’s our job. However, it helps to have as much information as you can provide about your device, when it was fitted, the symptoms you experienced, and any treatment or surgery you’ve had as a result.

Our team will obtain your medical records, work with independent medical experts to assess the impact of the device failure on your health, and build the evidence needed to support your claim. We’ll guide you through every step.

Yes. If you’ve lost a loved one and believe their death may be connected to a recalled Boston Scientific device, you may be able to bring a claim on their behalf. We understand how devastating this situation is, and we’ll handle your case with the utmost sensitivity and care. Please get in touch and we’ll explain your options.

You can contact our team by phone or by completing the online form to register your interest. One of our specialist solicitors will then be in touch to carry out a free case assessment, listen to your experience, and advise you on whether you have a valid claim. There is no obligation to proceed.

Pathological disruptions to the electrical system of the heart mean it can beat too quickly or slowly or in an uncoordinated way. Depending on the cause, a pacemaker or cardiac resynchronisation therapy device (“CRT”) may be needed. The pacemaker software is programmed to stop the resting pulse dropping below a certain level, usually about 60 beats per minute, If it goes below this the pacemaker will initiate an electrical impulse.

A CRT device is used for patients with ventricular desynchrony (where the ventricles don’t pump at the same time). This is a specialised pacemaker which paces both ventricles so they do beat at the same time. There are two types of CRTs. One is a CRT-P (CRT-pacemaker). This is described above and is the type relevant to this Boston Scientific recall case. The other is a CRT-D (CRT – defibrillator). The CRT-D is used for people who are at high risk of sudden cardiac death and can deliver a defibrillation shock if the heart goes into ventricular fibrillation or beats at a very high rate.

The issue with the pacemaker is thought to be due to a higher concentration of lithium in the cathode which they attribute to a variability of battery assembly techniques. They explain that high battery impedance may cause a device to exhibit transient voltage decreases, typically during telemetry, but this can happen at other times too. If the voltage drops below a minimum threshold, the system reset automatically happens and if 3 of these happen in 48hrs, the device goes into Safety Mode.

Once this happens, the healthcare professional should contact Boston through a remote management system. They explain that the devices are more susceptible to high battery impedance and going into Safety Mode when they have less than 4 years remaining battery life. Normally, there should be enough battery capacity for the device to work for 3 months while a replacement is scheduled. But if the pacemaker goes into Safety Mode due to high battery impedance, this ‘may not be sufficient to support device operations for three months and replacement is urgent.

There don’t appear to be any exact figures on this. However, in the Medical Device Alert of 2018, the MHRA reported that ‘there are approximately 32,500 affected patients at 308 centers in the UK. At the time of the recall, there had been 184 reported events worldwide (22 in the UK) representing 0.05% of sales of these device models. These include 31 known incidents of serious injury or death (8 in the UK) including patient dizziness, syncope or falls.