FDA Device recall Z-0739-2021
Medtronic Ares Antibiotic-Impregnated Catheter, REF: 93092, Sterile, Rx Only
- FDA Device
- Class II
- ongoing
- Published 2021-01-06
On 2021-01-06 the FDA classified a Class II recall of Medtronic Ares Antibiotic-Impregnated Catheter, REF: 93092, Sterile, Rx Only by Medtronic Neurosurgery, citing 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-o….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0739-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-12-08 |
| Published | 2021-01-06 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Medtronic Neurosurgery |
| Distribution | US |
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.
Reason
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.
Identifiers
| code_info | Lot numbers: 0010258435, 0010281390, 0010312360, 0010353505, 0010384900, 0010273889, 0010281391, 0010312361, 00…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0739-2021%22
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