Last Updated on December 26, 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.
-
What is atrial fibrillation?
Atrial fibrillation is a heart condition that causes irregular, rapid heartbeats.
-
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.
-
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.
Procedure to obtain license for manufacturing of Medical Devices
Procedure for registration of Medical Devices: CDSCO
Registration for sale of Medical Devices: Procedure and conditions
Latest Notifications: Medical Devices
Classifications of Medical Devices under the provisions of MDR 2017
Notified Bodies for Medical Devices
Updated list of Notified Bodies for Medical Devices
Updated list of Medical Device Testing Laboratories (MDTLs)
Forms: All types of Medical Devices
Schedules: All types of Medical Devices
Medical Device recall: Unauthorized Plastic Syringes recalled
Medical Device recall: USFDA classifies recall of Catheter Kits as ‘most serious’
Medical Device recall: USFDA classifies recall of this implant as ‘Most Serious’
Medical Device recall: USFDA classifies recall of this Scientific device as ‘most serious’
Medical Device recall: USFDA classifies recall of this Medical Device as most serious
NPPA: New Strategy to Curb Drug Price Hikes
Pharmexcil 2024 Elections: New Leadership for India’s Pharmaceutical Industry
Drug recall: 1,394 batches of drugs recalled in 2023-24 due to quality issues
Chemists want Ayurvedic Medicine Under FDA Scrutiny
USFDA issues warning letter to Indoco Remedies for Goa facility
Karnataka creates unified Food and Drug Administration (FDA)
CDSCO to undergo massive Expansion in the coming year
Key Notes on Revised Schedule M: Point No. 9 – Production under Loan License
Action against sale of habit-forming drugs without prescription: Tamil Nadu
Gujarat’s Medical Device Park: A Game-Changer for India’s Healthcare Sector
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
