Medtronic is recalling Rashkind balloon septostomy catheters because of quality problems that may lead to the device breaking, separating, or failing during use, which could cause serious harm, including vascular injury and death, the US Food and Drug Administration (FDA) has announced.
The FDA is categorizing the recall as class I, the most serious type.
Rashkind balloon septostomy catheters are used to create or enlarge an atrial septal defect in patients with cyanotic congenital heart defects.
The recall affects 142 of the devices distributed in the United States between May 28, 2018, and August 28, 2020, with product numbers 008764, 007160, and 007161. Information on individual lot numbers is available in the recall notice on the FDA website.
Medtronic has sent an Urgent Medical Device letter to all affected customers asking them to identify and quarantine all unused Rashkind balloon catheters affected by the recall and to contact Medtronic customer service at 1-888-283-7868 to initiate a product return.
Healthcare professionals and consumers can report adverse reactions or quality problems they experience using the devices to the FDA's MedWatch program.
Cite this: Medtronic Recalls Rashkind Balloon Septostomy Catheters - Medscape - Nov 04, 2020.