Rashkind Balloon Septostomy Catheter, 6F, Recess Balloon, Closed end, 50 cm, Pediatric, Single Lumen Product number: 008764 GTIN: 00613994760289 The Rashkind balloon septostomy catheters are designed for creating an atrial septal defect or enlarging an existing atrial septal defect as a treatment option for patients with a Cyanotic Congenital heart defect. Cyanotic congenital heart defects are rare conditions that are associated with high morbidity and mortality.

Subsequent failure of catheters in the field and failed quality testing

An immediate field corrective action was initiated by Medtronic field representatives. Customers were notified verbally to quarantine and return affected product on 25-Aug-2020. The following information was verbally provided to affected customers by Medtronic representative: "A supplier for Rashkind Catheter product has notified Medtronic that it has shipped product to Medtronic that may contain an issue. The supplier conducts a routine test in production. In two separate lots, the manufacturing specification was not met by all samples, but the lots were inadvertently shipped to Medtronic. We are requesting that you immediately refrain from using this product and place it in quarantine until further notice. You will be receiving an official recall notice with instructions for product return. Your Sales Representative will assist you with this process. We apologize for the inconvenience; however this action is necessary to ensure the utmost patient safety with the use of our products" In the United States on 09-Sep-2020, Medtronic began delivering an "Urgent Medical Device Recall" letter via UPS 2- day delivery to risk managers who, according to Medtronic records have received affected product. The notification states the following: 1. Identify and quarantine all unused Rashkind Balloon Catheters as listed in notification 2. 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. 3. Please complete the enclosed Customer Confirmation Form and email to [email protected]. Even if you do not have any product to return 4. Please forward the notice to all those who need to be aware within your organization.