Cook Medical Transseptal Needle Recall Issued Over Rust, Which Could Be Fatal
A global recall has been issued for all lots of Cook Medical Transseptal Needles, sold with or without catheters, due to a risk the device may have internal rust which poses a risk of permanent and potentially life-threatening injuries for patients.
The FDA announced the Transseptal Needle and Transseptal Needle with Catheter recall on October 19, after Cook Medical received at least four complaints about rust on the devices after they had been used on patients. While no injuries have been reported to date, this could pose serious risks during heart procedures.
The Cook Medical Transseptal Needle is used for transseptal left heart access in diagnostic and interventional procedures, to help transeptal entry into the left atrium of the heart for catheterization.
According to the complaints, rust was found internally, externally, or in both areas. As a result, Cook warns that the presence of rust may go undetected by medical providers.
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The company warns that using the products could result in increased procedural time in order for the healthcare provider to obtain a replacement device. Additionally, patients may experience an inflammatory reaction, including systemic reactions which require medical intervention, which may lead to permanent impairment or death.
The global recall includes all unexpired lots of the Transseptal Needle, reference part numbers (RPN) TSNC-18-71.0 and TSNC-19-56.0, and order number (GPN) G02364. It also includes all unexpired lots of the Transseptal Needle with Catheter, RPN TSN-17-75.0-ENDRYS and GPN G19261. All affected products have a range of manufacturing dates of October 02, 2016 through July 22, 2021.
Cook recommends customers discontinue use of the recalled products and return affected products back to the company. Customers that received affected products were issued prepaid labels in a return packet. Customers can also contact Cook Medical with questions about the recall at 800-457-4500.
Side effects experienced from using products affected by the recall should be reported to the FDA’s MedWatch Adverse Event Reporting program.