Imactis Navigation Kit — Class II medical device recall Z-0838-2020
Ongoing recall by Imactis, reported 2020-01-29, distributed in IL, WI. The firm has become aware that the sensor cover, a component of the single-use navigation kit may contain micr
| Recall number | Z-0838-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Imactis, St Martin D Heres, France |
| Recall initiated | 2019-08-01 |
| Classified | 2020-01-22 |
| Reported by FDA | 2020-01-29 |
| Distributed | IL, WI |
| Quantity | 122 kits |
| Reason classes | microbial contamination, sterility |
| Lot numbers | 18120001, 19040001 |
| Model numbers | 0459, 0482, 10100, 38.20.15CE, A10010CE, PC3688CE |
| Expiration dates | 2020-04-01, 2021-01-22 |
Product
Imactis Navigation Kit, REF 10100, Content Sterile Needle Holder Ref. A10010 CE 0459, Sensor Cover Ref. PC3688 CE 0482, Adhesif Film Ref. 38.20.15 CE 0459, EN Navigation Kit. Compatible with linear instruments of diameter ranging from 0.5 mm to 3.0 mm (25G to 11G), Sterile, Rx Only,
Reason for recall
The firm has become aware that the sensor cover, a component of the single-use navigation kit may contain microbial contamination. A source of microbial contamination has been identified in a raw product used to manufacture the tip of the cover.This could result in direct exposure of the intra-cardiovascular, intra-lymphatic or neurological system to a level of endotoxin sufficient to produce a pyrogenic response.
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-0838-2020. 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.