We just reported about a Boston Scientific recall, the Accolade Pacemaker recall. There is another Boston Scientific recall. This one concerns special cardiac catheters – the PolarX recall and the PolarX FIT recall.

Boston Scientific Updates Instructions for Cryoablation Balloons Following Reports of Severe Injuries

Boston Scientific, a large, global medical device company, updated instructions for the use of their PolarX™ and PolarX FIT™ Cryoablation Balloons. This Boston Scientific recall stems from reports of severe patient injuries surfaced. These changes, which include modified guidance on device operation, come in response to concerns over adverse events during procedures.

What Are Cryoablation Balloons?

Cryoablation balloons are specialized catheters used in minimally invasive procedures to treat atrial fibrillation (AFib), a common heart rhythm disorder. These devices operate by freezing cardiac tissue to isolate problematic electrical signals that cause irregular heartbeats. While effective when used correctly, the technology’s complexity introduces risks if not handled appropriately.

What is the PolarX Recall about? The Updated Instructions

The FDA announced on December 20, 2024, that Boston Scientific revised the instructions for their PolarX™ Cryoablation Balloon Systems. These updates aim to mitigate risks associated with catheter navigation and balloon inflation during ablation procedures. According to the FDA recall notice (source), the modifications emphasize:

• Enhanced precautions during catheter insertion.
• Adjusted inflation protocols to prevent over-expansion of the balloon.
• Training updates for healthcare professionals to ensure proper usage.

Why Did Boston Scientific Recall the Polar X to Update its Instructions? Reported Injuries

Several adverse events have been linked to the PolarX™ devices, including vascular damage and severe tissue injury. A summary from the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database revealed that these incidents often stem from over-inflation or misplacement of the catheter (FDA Database). The company’s proactive response highlights the importance of transparency and patient safety in the face of potential device-related complications.

Boston Scientific Recalls

This is not the first time Boston Scientific has faced scrutiny for their medical devices this month. Earlier this year, the company recalled specific models of pacemakers, including the Accolade™, Essentio™, and Visionist™, due to battery malfunctions. As we reported in a prior blog post (KBA Attorneys), these defects posed severe risks to patients, ranging from device failure to life-threatening complications. Read more here

Accolade Pacemaker: Accolade, Proponent, Essentio, Altrua, Visionist, and Valitude Pacemaker Recall

What Does this Mean for PolarX Patients?

We do not provide medical advice here, any patient with a PolarX or PolarX FIT should speak with their doctor. The Boston Scientific PolarX recall concerns mostly use of the device and therefore focuses on surgeons using it. Nonetheless, surgeons may have implanted or used the Polar X devices already without the benefit of these new instructions. Thus, patients may have PolarX complications.

What are PolarX Complications? What are Polar X Symptoms?

Patients who have undergone procedures involving the PolarX™ or PolarX FIT™ Cryoablation Balloons should consult their healthcare provider if they experience any unusual symptoms. Relevant Polar X complications or PolarX symptoms may include:

• Persistent chest pain.
• Difficulty breathing.
• Signs of vascular damage, such as bruising or swelling.

Boston Scientific’s updates are intended to enhance device safety, but patients must remain vigilant and informed.

What Should PolarX Patients Due if They Suffered an Injury? Protecting Your Rights

If you or a loved one has suffered injuries due to a Boston Scientific medical device, it’s essential to understand your legal rights. The experienced attorneys at Ketterer, Browne & Associates, LLC, represent clients in medical device injury cases. Our personal injury attorneys practice as product liability lawyers, and more specifically as medical device lawyers. We have successfully litigated cases involving defective high-risk devices. Every case is different and past results do not guarantee future success, so call us to see if we can help you. 855-KBA-LAWS (522-5297).

Contact us today for a free consultation to discuss your case. Our team is committed to holding manufacturers accountable and ensuring that your voice is heard.

Sources:

1. Benzinga, “Boston Scientific Updates Instructions for Cryoablation Balloons After Reports of Severe Injuries,” December 23, 2024. (source)
2. FDA Recall Notice, December 20, 2024. (source)
3. FDA MAUDE Database Summary. (source)