CLASS I ONGOING Device recall · Reported 30 Apr 2025 · FDA Enforcement Report

Novasight Hybrid System Novasight Hybrid Catheter recalled

Conavi Medical is recalling Novasight Hybrid System Novasight Hybrid Catheter, distributed in Georgia, New Jersey, New York, Ohio. The recall was initiated on 12 Mar 2025 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesModel 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).

Quantity recalled685

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1585-2025
FDA event ID: 96444
Recalling firm: Conavi Medical, Toronto, N/A
Classification: Class I
Status: Ongoing
Recall initiated: 12 Mar 2025
FDA classified: 23 Apr 2025
Reported: 30 Apr 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Heart & Vascular Devices

Timeline

12 Mar 2025	Recall initiated by company
23 Apr 2025	Classified by FDA	+42 days
30 Apr 2025	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Due to manufacturing issues there is a potential for the catheter sheath to detach.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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.

Where it was distributed

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

Georgia New Jersey New York Ohio

Questions about this recall

Why was it recalled?

Due to manufacturing issues there is a potential for the catheter sheath to detach.

Which lots are affected?

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).

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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