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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Medtronic Neuromodulation
- 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
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
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.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2172-2014
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