Target Detachable Coils: TARGET 360 NANO 1 MM X 3 CM MODEL Number:… — Class II medical device recall Z-2161-2016
Terminated recall by Stryker Neurovascular, reported 2016-07-20, distributed nationwide. Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch
| Recall number | Z-2161-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Neurovascular, Fremont, CA, United States |
| Recall initiated | 2016-06-06 |
| Classified | 2016-07-11 |
| Reported by FDA | 2016-07-20 |
| Terminated | 2017-03-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BG, BR, CA, CH, CL, CN, CO, CZ, DE, DK, EG, ES, FI, FR, GB, GR, HK, HR, HU, IE, IN, JP, KR, LB, LT, LU, LV, MX, NL, NO, PE, PH, PL, PT, RU, SA, SE, SG, SI, SK, TH, TR, UY, VN, ZA |
| Quantity | 45,302 |
| Lot numbers | 18393386, 18426357, 18462217, 18462274, 18469612, 18469669, 18488920, 18488978, 18535009, 18542421, 18542479, 18554193, 18554251, 18582681, 18590876, 18604392, 18604450, 18604508, 18604566, 18629171, 18629229, 18629287, 18638376, 18647637, 18653835, 18653893, 18654009, 18654067, 18666779, 18666837, 18666895, 18677403, 18677461, 18677519, 18677577, 18701840, 18701898, 18714304, 18714420, 18714536 and 48 more |
| Model numbers | M0035421030 |
Product
Target Detachable Coils: TARGET 360 NANO 1 MM X 3 CM MODEL Number: M0035421030 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Reason for recall
Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil stretching.
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-2161-2016. 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.