Use caution Medical device recall · FDA · Published August 1, 2019

Imactis Navigation Kit Recall: Microbial Contamination Risk

Imactis recalls navigation kits with potential microbial contamination in sensor covers, risking pyrogenic responses. Affected kits include specific model numbers and expiration dates.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0838-2020Medical device Imactis ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmImactis20 Rue Du Tour De L Eau · St Martin D Heres, France

✎ GovInfoNow plain-language explainer

Imactis is recalling navigation kits that may contain microbial contamination in the sensor cover. This could lead to serious health issues if the contaminated cover is used during medical procedures involving the heart, lymphatic system, or nerves. Read more at govinfonow.com/recall/67265-imactis-navigation-kit-recall-microbial-contamination-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/67265-imactis-navigation-kit-recall-microbial-contamination-risk · Updated August 17, 2026 · FDA enforcement record: FDA #Z-0838-2020

Cite this page

“Imactis Navigation Kit Recall: Microbial Contamination Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/67265-imactis-navigation-kit-recall-microbial-contamination-risk. Based on FDA recall #Z-0838-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0838-2020%22&limit=1).

The FDA announced on 2019-08-01 that Imactis is recalling its Navigation Kit, REF 10100, due to potential microbial contamination. This defect could expose patients to endotoxins sufficient to cause a pyrogenic response.

How to tell if you have it

Brand: Imactis
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
Lot # 18120001/Exp. 2020-04-01
Lot # 19040001/Exp. 2021-01-22

The hazard

The sensor cover may contain microbial contamination from a raw product used in manufacturing. 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.

Context

GovInfoNow's records show Imactis has issued two other recalls since 2020-08-24. On 2021-02-11, the company recalled its NaviKit Stereotaxic Accessory due to a risk of inaccurate needle placement. Other recent recalls of similar products include Medline Convenience Kits Recall: Contaminated Components Risk (2026-07-10) and Medline Convenience Kits Recall: Fungal Contamination Risk (2026-08-11).

How to tell if you have this one

Check for the model numbers REF 10100, Content Sterile Needle Holder Ref. A10010 CE 0459, and Sensor Cover Ref. PC3688 CE 0482. The kits were sold with expiration dates Lot # 18120001 (expiring April 2020) and Lot # 19040001 (expiring January 2021).

Brand
Imactis
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify the model numbers and expiration dates listed in the product description to confirm if your kit is affected.

Where it went and when

Where it was distributed

Distributed in Illinois and Wisconsin.

FDA distribution: “US: WI & IL” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Illinois, Wisconsin.

Recall timeline

FDA published this recall 6 months after the firm started it.

Aug 1, 2019Firm started the recall
Jan 22, 2020FDA classified it Class II
Jan 29, 2020Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/67265-imactis-navigation-kit-recall-microbial-contamination-risk">Imactis Navigation Kit Recall: Microbial Contamination Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0838-2020 (August 1, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0838-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.