Medtronic Rashkind Balloon Septostomy Catheter Recall Follows Death, Injury Reports

Following at least one reported death, federal health officials have announced a Class I recall for certain Medtronic catheters, due to a risk that the devices may break and separate from one another during heart procedures, increasing the risk of serious and potentially life threatening injuries.

The Medtronic catheter recall issued earlier this year has been upgraded to a Class I recall by the U.S. Food and Drug Administration (FDA) on November 3, warning of two reported injuries and one death linked to the devices breaking, separating or failing during use.

The recall impacts Medtronic Rashkind Balloon Septostomy Catheters used to enlarge an existing atrial septal defect as a treatment options for patients diagnosed with congenital heart defects, such as low blood oxygen levels.

According to the recall upgrade notice, Medtronic has become aware of quality issues in which the devices may break, separate or fail during use, posing an increased risk of blood vessel injuries, and even death. To date, Medtronic has become aware of at least two injuries and one death related to the defect.

The recall includes an estimated 142 Rashkind Balloon Septostomy Catheters manufactured by Medtronic that are marked with the product numbers 008764, 007160, and 007161. The devices were distributed to healthcare facilities from May 28, 2018 to August 28, 2020.

Medtronic initiated the recall on August 25, and subsequently issued an Urgent Medical Device letter to all affected customers with instructions to identify and quarantine all unused devices impacted by the recall and to contact the manufacturer for instructions on how to return the products.

Following the reported injuries and death, the FDA categorized the recall and a Class I, indicating it is the most serious of its kind and the use of the devices could lead to serious and permanent injuries, or death.

As a result of the potential life-threatening consequences posed by the devices, Medtronic has announced they have stopped manufacturing and distribution of the Rashkind Balloon Septostomy Catheters.

Customers with additional questions regarding the recall are being asked to contact Medtronic Customer Service at 888-283-7688.