Medtronic Ares Antibiotic-Impregnated Catheter — Class II medical device recall Z-0739-2021
Ongoing recall by Medtronic Neurosurgery, reported 2021-01-06, distributed nationwide. There is a potential for a defect on the seal of the outer pouch of catheters. The defect may compromise the s
| Recall number | Z-0739-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Neurosurgery, Irvine, CA, United States |
| Recall initiated | 2020-12-08 |
| Classified | 2020-12-28 |
| Reported by FDA | 2021-01-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BR, CA, CH, CL, CR, CY, CZ, DE, DK, DO, EG, ES, FI, GB, GR, HK, HR, HU, IE, IL, IN, IR, IT, LV, MY, NG, NL, NO, NZ, PK, PL, PT, QA, RS, SA, SE, SG, TH, TW, VN, ZA |
| Quantity | 1,926 units |
| Reason classes | sterility, packaging |
| Lot numbers | 0010258435, 0010273889, 0010273890, 0010273891, 0010273893, 0010278418, 0010278427, 0010281384, 0010281390, 0010281391, 0010281392, 0010289835, 0010289836, 0010297678, 0010305929, 0010305937, 0010312360, 0010312361, 0010312362, 0010316959, 0010316960, 0010316961, 0010316963, 0010336620, 0010353505, 0010353507, 0010369366, 0010369367, 0010376784, 0010376785, 0010376786, 0010384897, 0010384900, 0010384901, 0010384903, 0010393220, 0010393221 |
| Model numbers | 93092 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0739-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.