Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1585-2025 — 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 translumi

U.S. FDA — Device Enforcement · Canada · 2025-03-12 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1585-2025
Date of alert: 2025-03-12
Country / jurisdiction: Canada
Risk level: Class I
Risk type: recall
Brand: Conavi Medical Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00628055603054

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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