Class 2 Device Recall Ascenda Intrathecal Catheter

• Date Initiated by Firm: July 11, 2014
• Date Posted: August 08, 2014
• Recall Status: Terminated on July 17, 2015
• Recall Number: Z-2172-2014
• Recall Event ID: 68838
• PMA Number: P860004S125
• Product Classification: Pump, infusion, implanted, programmable - Product Code LKK
• 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.
• Code Information: 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.
• Recalling Firm/ Manufacturer: Medtronic Neuromodulation; 7000 Central Ave Ne; Minneapolis MN 55432-3568
• For Additional Information Contact: Technical Service; 800-707-0933
• Manufacturer 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
• FDA Determined Cause: Nonconforming Material/Component
• Action: 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.
• Quantity in Commerce: 1200 (551 US, 649 OUS)
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = LKK and Original Applicant = MEDTRONIC Inc.