# FDA recall Z-0838-2020

> **Imactis** · Class II · device recall initiated 2019-08-01.

## 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.

## Distribution

US: WI & IL

## Key facts

- **Recall number:** Z-0838-2020
- **Recalling firm:** Imactis
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-08-01
- **Report date:** 2020-01-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** St Martin D Heres, France

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0838-2020

## Citation

> AI Analytics. FDA recall Z-0838-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0838-2020. Source: US FDA. Licensed CC0.

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