Catheters recalled due to defect—FDA highlights risk of stroke or brain damage
The U.S. Food and Drug Administration (FDA) has announced that Balt USA, the U.S. division of Balt Incorporated, is recalling certain catheters due to the discovery of a hydrophilic coating on the inside of the device.
This is a Class I recall, which indicates the issue could result in serious injuries or death.
The device in question is Balt USA’s Mega Ballast Distal Access Platform. It is used to help clinicians navigate through a patient’s blood vessels during various cardiovascular or neurovascular procedures. The Mega Ballast Distal Access Platform includes a dilator tool with a “special slippery coating” on its outer surface. It was designed to be used once and then discarded.
“This coating material is not supposed to be inside the device’s inner tube and represents a manufacturing defect,” according to the FDA advisory. “The use of affected product may cause serious adverse health consequences, including blood clots that can travel to vital organs, direct damage to blood vessels, blocked blood vessels, blood clot events including stroke, harmful immune system reactions, infections, reduced blood flow to tissues, nerve damage or loss of brain function and death.”
At this time, however, no injuries or deaths have been reported to the FDA.
Hospitals are urged to stop using these devices immediately. In addition, all employees should be alerted to ensure they are not used in the future. Medical device distributors are advised to stop selling the Mega Ballast Distal Access Platform, return any devices on hand to Balt USA and inform customers as needed.
Models/Unique Device Identifiers impacted by this recall include:
- Model No MEGABT09180 (00840303711780)
- Model No MEGABT09190 (00840303711797)
- Model No MEGABT091100 (00840303711803)
- Model No MEGABT091110 (00840303711810)
Click here for additional details about this Class I recall.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.