Reported Apr 30, 2025 · Ongoing
Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Model/Catalog Number: TA-06-0001 Product…
Conavi Medical Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Conavi Medical Inc. · 293 Lesmill Rd · Toronto, N/A · N/A
Is this the product you have?
- Brand NameNovasight
- Hybrid System Product NameNovasight
- Hybrid Catheter Model/Catalog NumberTA-06-0001
- Product DescriptionCommon
- NameDiagnostic
- intravascular catheter DescriptionThe 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
- PackagingThe Novasight Hybrid Catheter is packaged in a packaging system including the protective packaging and the sterile barrier system
- Lot codes and dates
11 of 11 products
Products covered by this recall Model / number Barcodes Product as published TA-06-000100628055603054UDI-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). - Amount recalled
- 685
Where it was sold
Why it was recalled
Stop using this product now
Due to manufacturing issues there is a potential for the catheter sheath to detach.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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