Medtronic: Rashkind balloon septostomy catheters
Medtronic initiated a recall of its Rashkind balloon septostomy catheters in August last year. The FDA designated the recall Class I on Nov. 3.
The recall involved 142 devices, which are designed to create an atrial septal defect or enlarge an existing atrial septal defect to treat congenital heart defects. The devices have quality issues that could lead to the device breaking, separating or failing during use. Adverse events could cause serious health consequences, including damage to blood vessels and death.
Fridley, Minn.-based Medtronic had two reported injuries and one death related to the device, according to a Nov. 3 FDA warning letter.
Medtronic has stopped making and distributing the Rashkind balloon septostomy catheters for reasons unrelated to the recall.
Catheters involved in the recall were distributed between May 28, 2018 and Aug. 28, 2020.
“To date, all customers have confirmed notification of the issue and have been asked to return all unused inventory to Medtronic. Medtronic is committed to patient safety and has communicated this information to the appropriate regulatory agencies,” a Medtronic spokesperson told Medical Tubing + Extrusion in an email.