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FDA Issues a Class One Recall on Medtronic Catheters

January 7, 2021 in

On November 3, 2020, the Food and Drug Administration  (FDA) issued a Class I recall, the most serious type of recall, for the Medtronic Rashkind Balloon Septostomy Catheter. The recall follows at least one reported death and two severe injuries sustained by Medtronic catheter users. The catheters are used during surgery to create an atrial septal defect or to enlarge an existing atrial septal defect as a treatment option for patients with cyanotic congenital heart defects. 

 

Quality Issues Pose Greatest Risk to Users

 

According to recent reports, quality control is cited as the primary reason for the recall. In September 2020, Medtronic issued a letter to health care professionals about the recall of all Rashkind Balloon Septostomy Catheters. The class one recall upgrade notice suggests 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. Medtronic sent out its own letter on Sept. 9, urging affected customers to return their catheters.

 

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

 

Read the FDA’s full recall notice here.

 

Speak With a Product Liability Attorney at Sullivan Papain Block McGrath Coffinas & Cannavo P.C.

 

The dedicated product liability attorneys at Sullivan Papain Block McGrath Coffinas & Cannavo, P.C. advocate for victims of negligent practices by companies who have a social responsibility to uphold and prioritize public health. If you or a loved one have been injured after using any Rashkind Balloon Septostomy Catheters, contact the team of New York product liability attorneys at Sullivan Papain Block McGrath Coffinas & Cannavo, P.C. today.

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