Medtronic Neuromodulation Medtronic Ascenda Intrathecal Catheter, Models: a) 8780 (114 cm); b) 8781 (140 cm); c) 8784 (catheter pump revision kit) Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Design update to the Ascenda Intrathecal Catheter Models 8780, 8781, and 8784. The intent of the design update is to reduce the potential for tissue growth into the Ascenda catheter connector which may potentially lead to catheter occlusion.

Recommended Action

Per FDA guidance

Medtronic issued an URGENT: MEDICAL DEVICE CORRECTION notice to its consignees on 05/10/2024 electronically (DocuSign) to each listed physician. For Physicians that do not have an email address or a DocuSign account, the Consignee Notification and Customer Confirmation Form were sent via mail UPS/USPS. The notice explained the issue, provided clinician and patient recommendations, and requested that the notice be shared with all those to whom the devices was transferred. If you have any questions regarding this communication, please contact Medtronic Technical Services at 1-800-707-0933 or your local Medtronic representative. On 03/12/2025, Medtronic issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees via mail. The Consignee Notifications informs the customer of availability of Ascenda catheters with the new design and requests the return of Ascenda catheters that were manufactured prior to the design update of 05/10/2024, and requested that the notice be shared with all those to whom the devices was transferred. For questions, please contact Medtronic Technical Services at 1-800-707-0933 or your local Medtronic representative.