Z-1585-2025Class I

Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Model/Catalog Number: TA-06-0001...

Name: Z-1585-2025 Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Model/Catalog Number: TA-06-0001...
Creator: Conavi Medical Inc.
Published: 2025-03-12
License: https://open.fda.gov/license/

Conavi Medical Inc / initiated 2025-03-12 / Open, Classified / root cause: manufacturing process

FDA source

Conavi Medical Inc. began a recall of Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Model/Catalog Number: TA-06-0001 Product Description: Common Name: Diagnostic... on 2025-03-12. FDA classified it as Class I and gives the reason as "Due to manufacturing issues there is a potential for the catheter sheath to detach". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1585-2025
Classification: Class I
Status: Open, Classified
Initiated: 2025-03-12
Posted: 2025-04-23
Recalling firm: Conavi Medical Inc
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.
Product code: OBJ Catheter, Ultrasound, Intravascular
Reason for recall: Due to manufacturing issues there is a potential for the catheter sheath to detach.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 03/12/2025, the firm sent via email an "URGENT: MEDICAL DEVICE VOLUNTARY RECALL" Letter informing customer that the firm has become aware that the sheath of the Novasight Hybrid catheter detached and left in the patient's body during a clinical case but was retrieved during the procedure. Customers are instructed to: Customers shall stop/cease use of the affected the Novasight Hybrid catheters and remove them from service and return immediately to Conavi Medical Inc. This applies to all Novasight Hybrid catheters shipped to U.S.A. regardless of expiry dates. Acknowledge receipt of this recall notification by completing and returning the "Acknowledgement" section of this notification by email to: [email protected]. For questions or assistance - Contact information: Director of Product Management and Marketing Telephone # (416)-483-0100 Ext 109, Email: [email protected] Days/Hours Available for calls: Monday through Friday, 9:00 AM to 4:30 PM Eastern Time.
Quantity in commerce: 685
Distribution: US distribution to states of: GA, NY, NJ, OH; and OUS (Foreign) to countries of: Canada and China
Product codes and lots: 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).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1585-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1585-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-04-30	2025-04-23

Product code OBJ

K172258Class IINovasight Hybrid SystemConavi Medical, Inc. / cleared 2018-04-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)