Cook Medical this week announced a global voluntary recall of its Transseptal Needle and Transseptal Needle with catheter.
Bloomington, Indiana-based Cook Medical issued the recall due to complaints of rust on the products. The use of both products could result in increased procedural time and inflammatory reactions, including systemic reactions that could lead to permanent impairment or death, according to the company.
There have been no reports of injury or illness related to the recall. Cook Medical has received four complaints in which rust was identified prior to patient contact. The company advises that the presence of rust could go undetected by users.
The voluntary recall includes all unexpired lots of both products that were manufactured between Oct. 2, 2016, and July 22, 2021.
Cook Medical Transseptal Needle is intended for transseptal left heart access in both diagnostic and interventional procedures. The needle with catheter is intended to facilitate transseptal entry into the left atrium.
Cook Medical recommends that users check inventories for affected units and return all devices.