Medtronic Ares Antibiotic-Impregnated Catheter — Class II medical device recall Z-0738-2021
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-0738-2021 |
|---|---|
| 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 | 3,165 units |
| Reason classes | sterility, packaging |
| Lot numbers | 0010052549, 0010052552, 0010149011, 0010149013, 0010258434, 0010265136, 0010265137, 0010265138, 0010278408, 0010278409, 0010289827, 0010289828, 0010289829, 0010289830, 0010289831, 0010289833, 0010289834, 0010297686, 0010297689, 0010297691, 0010297693, 0010297696, 0010305912, 0010305919, 0010305920, 0010305921, 0010305923, 0010305926, 0010316955, 0010316956, 0010316957, 0010316958, 0010336617, 0010336618, 0010336619, 0010353500, 0010353501, 0010353502, 0010353503, 0010353504 and 17 more |
| Model numbers | 91101 |
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 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-0738-2021. 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.