Recall Z-2352-2024 ยท LKK Pump, Infusion, Implanted, Programmable
Medtronic Neuromodulation
Medtronic Ascenda Intrathecal Catheter, Models: a) 8780 (114 cm); b) 8781 (140 cm); c) 8784 (catheter pump revision kit)
| Date | Jul 12, 2024 (initiated May 10, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Device Design |
| Action | 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 y |
| Quantity | 111762 units |
| Distribution | Worldwide Distribution: US (nationwide) and OUS (foreign) countries of: Argentina, Aruba, Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Chile, Colombia, Cyprus, Czech Rep, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Guadeloupe, Germany, Greece, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.