FDA Device recall Z-0738-2021
Medtronic Ares Antibiotic-Impregnated Catheter, REF: 91101, 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: 91101, 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-0738-2021 |
| 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: 91101, 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: 0010052549, 0010289829, 0010305920, 0010353501, 0010384893, 0010052552, 0010289830, 0010305921, 00…Lot Numbers: 0010052549, 0010289829, 0010305920, 0010353501, 0010384893, 0010052552, 0010289830, 0010305921, 0010353502, 0010384894, 0010149011, 0010289831, 0010305923, 0010353503, 0010384895, 0010149013, 0010289833, 0010305926, 0010353504, 0010384896, 0010258434, 0010289834, 0010316955,, 0010369362, 0010393213, 0010265136, 0010297686, 0010316956, 0010369364, 0010393215, 0010265137, 0010297689, 0010316957, 0010369365, 0010393216, 0010265138, 0010297691, 0010316958, 0010376787, 0010393814, 0010278408, 0010297693, 0010336617, 0010376788, 0010393839, 0010278409, 0010297696, 0010336618, 0010376789, 0010289827, 0010305912, 0010336619, 0010376790, 0010289828, 0010305919, 0010353500, 0010384892 |
|---|
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-0738-2021%22
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