FDA Device recall Z-2172-2014

Medtronic Ascenda Intrathecal Catheter models 8780 and 8781, and Ascenda Intrathecal Catheter Pump Segment Revision Kit, model 8784

FDA Device
Class II
terminated
Published 2014-08-20

On 2014-08-20 the FDA classified a Class II recall of Medtronic Ascenda Intrathecal Catheter models 8780 and 8781, and Ascenda Intrathecal Catheter Pump Segment Revision Kit, model 8784 by Medtronic Neuromodulation, citing medtronic is removing specific lots of the Ascenda Intrathecal Catheters and Revision Kits, which are used with the implantable SynchroMed drug infusion pump. This recall is being….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2172-2014
Classification	Class II
Status	terminated
Initiated	2014-07-11
Published	2014-08-20
Last updated	2026-09-13 11:53 UTC
Company	Medtronic Neuromodulation
Distribution	US

Product

Medtronic Ascenda Intrathecal Catheter models 8780 and 8781, and Ascenda Intrathecal Catheter Pump Segment Revision Kit, model 8784. The Ascenda Intrathecal Catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space. The implanted infusion system components consist of a Medtronic pump and an Ascenda Intrathecal Catheter.

Reason

Medtronic is removing specific lots of the Ascenda Intrathecal Catheters and Revision Kits, which are used with the implantable SynchroMed drug infusion pump. This recall is being conducted due to a single component of the catheter, the retainer ring, not meeting specification criteria. There is a possibility of unintentional disconnection of the catheter from the pump, or difficulty in disconne

Identifiers

code_info	Serial Numbers are in the following format: "N" + 9 digits (e.g. N12345001. Product beginning with the following lett… Serial Numbers are in the following format: "N" + 9 digits (e.g. N12345001. Product beginning with the following letter/number combinations are affected: N464184, N464200, N464206, N464254, N464257, N464258, N464262, N464263, N464264, N464271, N464693, N464703, N464708, N464725, N464727, N464730, N464734, N464736, N464738, N464742, N464746, N464750, N464752, N464841, N464924, N464930, N464995, N464995, N465020, N465038, N465063, N465065, N465073, N465082, N465088, N465091, N465094, N465111, N465125, N465129, N465131, N465136, N465138, N465144, N465145, N465146, N465148, N465150, N466065, N466067, N466067, N466068, N466069, N466071, N466072, N466075, N466134, N466167, N466177, N466196, N466201, N466240, N466244, N466259, N466289, N466290, N466291, N466306, N466368, N466390, N466392, N466394, N466398, N466399, N466631, N466639, N466645, N466678, N466678, N466754, N466758, N466761, N466886, N466897, N466901, N466902, N466911, N466914, N467103, N467109, N467113, N467114, N467116, N46712

code_info

Serial Numbers are in the following format: "N" + 9 digits (e.g. N12345001. Product beginning with the following lett…

Serial Numbers are in the following format: "N" + 9 digits (e.g. N12345001. Product beginning with the following letter/number combinations are affected: N464184, N464200, N464206, N464254, N464257, N464258, N464262, N464263, N464264, N464271, N464693, N464703, N464708, N464725, N464727, N464730, N464734, N464736, N464738, N464742, N464746, N464750, N464752, N464841, N464924, N464930, N464995, N464995, N465020, N465038, N465063, N465065, N465073, N465082, N465088, N465091, N465094, N465111, N465125, N465129, N465131, N465136, N465138, N465144, N465145, N465146, N465148, N465150, N466065, N466067, N466067, N466068, N466069, N466071, N466072, N466075, N466134, N466167, N466177, N466196, N466201, N466240, N466244, N466259, N466289, N466290, N466291, N466306, N466368, N466390, N466392, N466394, N466398, N466399, N466631, N466639, N466645, N466678, N466678, N466754, N466758, N466761, N466886, N466897, N466901, N466902, N466911, N466914, N467103, N467109, N467113, N467114, N467116, N46712

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2172-2014%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.