Medtronic Inc. is recalling Rashkind Balloon Septostomy Catheters because of device quality issues that may lead to the device breaking, separating or failing during use, which may cause serious adverse health consequences such as damage to blood vessels (vascular injury) and death, stated the U.S. Food and Drug Administration (FDA). There have been two reported injuries and one death.
The FDA has identified this as a Class I recall, the most serious type of recall as use of these devices may cause serious injuries or death.
Device information:
· Rashkind Balloon Septostomy Catheter
· Lot Numbers: See the Recall database entries below for lot numbers
· Product Numbers: 008764, 007160, and 007161
· Distribution Dates: May 28, 2018 to August 28, 2020
· Devices Recalled in the U.S.: 142
· Date Initiated by Firm: August 25, 2020
The Rashkind Balloon Septostomy Catheters are used 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.
Additionally, Medtronic has stopped the manufacturing and distribution of Rashkind Balloon Septostomy Catheters due to reasons unrelated to this recall.
Healthcare providers using the affected Rashkind Balloon Septostomy Catheters
On September 9, 2020 Medtronic sent an Urgent Medical Device letter to all affected customers with the following instructions:
· Identify and quarantine all unused Rashkind Balloon Catheters affected by the recall.
· Return all unused affected product in your inventory to Medtronic. Contact Medtronic Customer Service at 1-888-283-7868 to initiate a product return. Your local Medtronic Representative can assist you in the return of this product.
