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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices/Diagnostic Equipment

Novasight Hybrid Catheters Recalled for Potential Sheath Detachment

Agency Publication Date: April 23, 2025
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Summary

Conavi Medical Inc. has recalled approximately 685 Novasight Hybrid Catheters (Model TA-06-0001) due to a manufacturing issue that could cause the catheter sheath to detach. The Novasight Hybrid catheter is a medical device used by healthcare professionals for simultaneous ultrasound and optical imaging of a patient's blood vessels. There have been no reported incidents or injuries associated with this issue at this time.

Risk

If the catheter sheath detaches during a medical procedure, it could lead to complications for the patient, including the need for additional procedures to retrieve the detached component from the body.

What You Should Do

  1. This recall affects the Novasight Hybrid Catheter (Model TA-06-0001) with lot numbers 230902, 240202, 240302, 240402, 240502, and all catheter lots that have already expired.
  2. Stop using the recalled device immediately.
  3. Contact Conavi Medical Inc. or your authorized medical distributor to arrange for the return, replacement, or correction of the affected catheters.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for more information.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Novasight Hybrid Catheterby Novasight Hybrid System
Model / REF:
TA-06-0001
Lot Numbers:
230902 (Exp 2024-06)
240202 (Exp 2025-03)
240302 (Exp 2025-04)
240402 (Exp 2025-05)
240502 (Exp 2025-06)
UDI:
(01)00628055603054

Includes all catheter lots which were expired (See attachment 2a, 2b and 2c for details).

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96444
Status: Active
Manufacturer: Conavi Medical Inc.
Sold By: Authorized Medical Distributors
Manufactured In: Canada
Units Affected: 685
Distributed To: Georgia, New York, New Jersey, Ohio

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.