Recall Z-0537-2018 ยท LKK Pump, Infusion, Implanted, Programmable
Medtronic Neuromodulation
Medtronic Ascenda(R) Intrathecal Catheter, Models: (a) 8780, UDI: 00643169202122, 00643169783027 (b) 8781, UDI: 00643169202139 (c) 8784, UDI: 00643169202153 The Ascenda Intrathecal Catheter kits (models 8780, 8781 and 8784) contain parts of an infusion system that delivers drugs to the intrathecal space. The implanted system consists of an implantable infusion pump and an Ascenda catheter. The
| Date | Feb 6, 2018 (initiated Sep 21, 2017) |
| Status | Terminated |
| Reason | There is a possibility that specific lots of catheters that have recently been distributed may be at risk for an increased potential for kinking at the proximal end where the catheter connects to the drug infusion pump. |
| Root cause | Other |
| Action | Medtronic on September 21, 2017, initiated a medical device recall and sent the following via mail (with delivery confirmation) to the consignees. In addition to the mailing, Medtronic field representatives may personally visit the accounts to provide the recall notification, assist the customer as necessary with locating and returning affected product(s), and verify that the customer has or will respond to Medtronic with the Customer Confirmation Form. For further questions, please call (800) 707-0933. |
| Quantity | 194 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.