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.
This recall has been terminated (originally issued August 8, 2014).
- Company
- Medtronic Neuromodulation
- Recall Initiated
- July 11, 2014
- Posted
- August 8, 2014
- Terminated
- July 17, 2015
- Recall Number
- Z-2172-2014
- Quantity
- 1200 (551 US, 649 OUS)
- Firm Location
- Minneapolis, MN
- Official Source
- View on FDA website ↗
Reason for Recall
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
Distribution
Worldwide Distribution - USA (nationwide) including the states of AL,AR,AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, Ml, MN, MO, MS, MT, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI and WV., and the countries of Austria, Belgium, Cyprus, Denmark, France, Germany, Iraq, Italy, Lebanon, Netherlands, Panama, Poland, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, United Kingdom and Uruguay.
Lot / Code Info
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, N467126, N467138, N467171, N467180, N467183, N467192, N467193, N467194, N467195, N467197, N467198, N467203, N467204, N467206, N467209, N467351, N467351, N467352, N467355, N467356, N467357, N467395, N467399, N467401, N467402, N467407, N467444, N467451, N467453, N467454, N467563, N467568, N467570, N467601, N467606, N467608, N467609, N467611, N467612, N467614, N467618, N467621, N467626, N468288, N468343, N468401, N468404, N468406, N468406, N468448, N468494, N468500, N468507, N468510, N468511, N468514, N468516, N468519, N468522, N468574, N468580, N468621, N468622, N468624, N468626, N468641, N469182, N469262, N469332, N469360, N469360, N469388, N469420, N469422, N469428, N469431, N469433, N469434, N469436, N469438, N469440, N469446, N469447, N469449, N469452, N469460, N469465, N469466, N469469, N469474, N469478, N469507, N469511, N469530, N469533, N469549, N469579, N469583, N469586, N469588, N470163, N470197, N470234, N470303, N470307, N470401, N470408, N470414, N470420, N470424, N470453, N470459, N470919, N470923, N470929, N470931, N470931, N470934, N470938, N470940, N470941, N470951, N470953, N470954, N471442, N471443, N471446, N471447, N471448, N471449, N471487, N471488, N471490, N471490, N471491, N471764, N471791, N471840, N471853, N471856, N471860, N471863, N471864, N471865, N471866, N471870, N471871, N471875, N471880, N472310, N472326, N472333, N472336, N472342, N472345, N472347, N472857, N472861, N472866, N472868, N472873, N472875, N472876, N472878, N472882, N472885, N472886, N472890, N472894, N472900, N472905, N473140, N473144, N473148, N473154, N473156, N473176, N473178, N473180, N473202, N473207, N473211, N473221, N473222, N473223, N473228, N473230, N473311, N473311, N473323, N473377, N473401, N473426, N473438, N473492, N473493, N473989, N473996, N473999, N474001, N474005, N474006, N474007, N474010, N474018, N474019, N474023, N474027, N474037, N474038, N474047, N474047, N474421, N474423, N474427, N474431, N474433.
Root Cause
Nonconforming Material/Component
Action Taken
Medtronic sent an Urgent Medical Device Removal letter dated July 11, 2014, to all affected customers. The letter described the issue, identified affected product, provided patient management recommendations for patients implanted with an affected device, asked for Risk Management to quaratine unused inventory within the hospital, and to contact Medtronic Customer Service at 1-888-638-7627 to facilitate return of devices.