Last Updated on December 19, 2024 by The Health Master
Medical Device recall
The U.S. Food and Drug Administration (USFDA) has issued a serious medical device recall for Boston Scientific’s POLARx Cryoablation Balloon Catheters.
These devices are used in minimally invasive procedures to treat atrial fibrillation, a heart condition that causes irregular heartbeats.
The Problem
The USFDA has classified this medical device recall as the most serious type because of a higher-than-expected number of reported injuries and deaths linked to the use of these catheters.
Specifically, the devices have been associated with:
- Esophageal injury: This can lead to a serious complication known as atrio-esophageal fistula, which can cause air bubbles to block blood vessels in the brain.
- Gastrointestinal bleeding: This can result in significant blood loss and other health problems.
- Systemic infection: This can spread throughout the body and lead to severe illness.
What’s Being Done
Boston Scientific is taking steps to address the issue by:
- Updating Instructions for Use: The company is revising the instructions to provide healthcare providers with important information about potential risks and how to minimize them.
- Medical Device Advisory: Boston Scientific has issued an urgent medical device advisory to all affected customers, outlining the specific steps they should take.
What Patients Should Know
If you have had a procedure using a POLARx Cryoablation Balloon Catheter, it’s important to:
- Monitor for Symptoms: Be aware of the potential symptoms of complications, such as chest pain, difficulty swallowing, or severe abdominal pain.
- Contact Your Healthcare Provider: If you experience any concerning symptoms, contact your doctor immediately.
- Stay Informed: Keep up-to-date on any new information or related to medical device recall.
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What is atrial fibrillation?
Atrial fibrillation is a heart condition that causes irregular, rapid heartbeats.
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What is a minimally invasive procedure?
A minimally invasive procedure is a surgical technique that involves smaller incisions, resulting in less pain and quicker recovery times.
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What should I do if I have concerns about a medical device?
If you have concerns about a medical device, you should contact your healthcare provider or report the issue to the USFDA.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
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