Novasight Hybrid Catheter Recalled for Potential Sheath Detachment
Conavi Medical Inc. is recalling the Novasight Hybrid Catheter (Model TA-06-0001) due to manufacturing issues that could cause the catheter sheath to detach. The device is used for diagnostic intravascular imaging.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I medical device recall, which per the rubric must score no lower than 4. The hazard (catheter sheath detachment during an intravascular procedure) poses a direct risk of serious injury to patients undergoing cardiac or vascular imaging.
Plain-English summary
Conavi Medical Inc. is recalling the Novasight Hybrid Catheter, a diagnostic intravascular catheter used to perform transluminal ultrasound and optical coherence tomography imaging in adults. The recall is due to manufacturing issues that create a potential for the catheter sheath to detach during use.
A total of 685 units have been distributed in the United States (Georgia, New York, New Jersey, and Ohio) and internationally (Canada and China). The affected product has model number TA-06-0001 and includes multiple lot numbers with varying expiration dates: lot 230902 (expired June 2024), lot 240202 (expires March 2025), lot 240302 (expires April 2025), lot 240402 (expires May 2025), lot 240502 (expires June 2025), and all expired catheter lots.
Healthcare providers and patients who have received this device should stop using it immediately and contact Conavi Medical Inc. for further instructions. Anyone with questions or concerns about their use of the Novasight Hybrid Catheter should reach out to their healthcare provider or the manufacturer.
The recalled product
- 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
- Manufacturer
- Conavi Medical Inc.
- Hazard
- device-failure
- sheath-detachment
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- 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).
Distribution
Distributed in 4 states:
- GA
- NJ
- NY
- OH
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