---
title: "Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter M... — FDA record Z-1585-2025 | Is It on Recall"
description: "Due to manufacturing issues there is a potential for the catheter sheath to detach."
url: https://isitonrecall.com/recall/fda-device-z-1585-2025-brand-name-novasight-hybrid-system-product-name-novasight-hybrid-catheter-model-catalog-number-ta-06/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Model/Catalog Number: TA-06-0001 Product ... — FDA record Z-1585-2025

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Mar 12, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Model/Catalog Number: TA-06-0001 Product Description: Common Name: Diagnostic intravascular catheter Description: The Novasight Hybrid catheter is a 3Fr single use, sterile device, which will be able to perform transluminal ultrasound and optical coherence tomography imaging of adults. The catheter is capable of real-time 2D side viewing ultrasound and optical imaging acquired simultaneously providing precisely co-registered images with the ability to produce rapidly post processed rendered longitudinal images of the vessel. Packaging: The Novasight Hybrid Catheter is packaged in a packaging system including the protective packaging and the sterile barrier system.
- **Reason**: Due to manufacturing issues there is a potential for the catheter sheath to detach.
- **Classification**: Class I
- **Recalling firm**: Conavi Medical Inc.
- **Quantity**: 685
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-1585-2025

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1585-2025%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Model No: TA-06-0001 UDI-DI: (01)00628055603054 Lot number: 230902; Expiration date: 2024-06; Lot number: 240202; Expiration date: 2025-03; Lot number: 240302; Expiration date: 2025-04; Lot number: 240402; Expiration date: 2025-05; Lot number: 240502; Expiration date: 2025-06; and all catheter lots which were expired (See attachment 2a, 2b and 2c for details). |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

US distribution to states of: GA, NY, NJ, OH; and OUS (Foreign) to countries of: Canada and China

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Georgia](https://isitonrecall.com/state/georgia/)
- [New Jersey](https://isitonrecall.com/state/new-jersey/)
- [New York](https://isitonrecall.com/state/new-york/)
- [Ohio](https://isitonrecall.com/state/ohio/)

## Dates in the source

- **Report date**: Apr 30, 2025
- **Recall initiation date**: Mar 12, 2025
- **Center classification date**: Apr 23, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1585-2025%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Conavi Medical Inc. records](https://isitonrecall.com/brand/conavi-medical-inc/)