medical Class II Updated 2021-01-06

Medtronic Neurosurgery recalls Medtronic Ares Antibiotic-Impregnated Catheter, REF: 93092,

Recalled Product

Medtronic Ares Antibiotic-Impregnated Catheter, REF: 93092, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.

Hazard / Issue

There is a potential for a defect on the seal of the outer pouch of catheters. The defect may compromise the sterility of the pouch contents, which may increase the risk of post-operative infection, requiring further medical intervention.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: Lot numbers: 0010258435, 0010281390, 0010312360, 0010353505, 0010384900, 0010273889, 0010281391, 0010312361, 0010353507, 0010384901, 0010273890, 0010281392, 0010312362, 0010369366, 0010384903, 0010273891, 0010289835, 0010316959, 0010369367, 0010393220, 0010273893, 0010289836, 0010316960, 0010376784, 0010393221, 0010278418, 0010297678, 0010316961, 0010376785, 0010278427, 0010305929, 0010316963, 0010376786, 0010281384, 0010305937, 0010336620, 0010384897

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