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Soft-Vu 10710049

by Angiodynamics, Inc. GUDID

Withdrawn United States

Regulatory status

as of 28 Oct 2026

Recall ongoing. 18 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberH787107100490 UDI-DIDate29 Apr 2019ListedStatusWithdrawn

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — GUDID listing Listed

Recalls

18 recalls · 18 ongoing · FDA

  • 16 recalls, same reason

    • Ongoing Z-1862-2026 FDA Class II initiated 3 Mar 2026
    • Ongoing Z-1863-2026 FDA Class II initiated 3 Mar 2026
    • Ongoing Z-1866-2026 FDA Class II initiated 3 Mar 2026
    • Ongoing Z-1859-2026 FDA Class II initiated 3 Mar 2026
    • Ongoing Z-1871-2026 FDA Class II initiated 3 Mar 2026
    • Ongoing Z-1858-2026 FDA Class II initiated 3 Mar 2026
    • Ongoing Z-1860-2026 FDA Class II initiated 3 Mar 2026
    • Ongoing Z-1864-2026 FDA Class II initiated 3 Mar 2026
    • Ongoing Z-1870-2026 FDA Class II initiated 3 Mar 2026
    • Ongoing Z-1856-2026 FDA Class II initiated 3 Mar 2026
    • Ongoing Z-1869-2026 FDA Class II initiated 3 Mar 2026
    • Ongoing Z-1867-2026 FDA Class II initiated 3 Mar 2026
    • Ongoing Z-1865-2026 FDA Class II initiated 3 Mar 2026
    • Ongoing Z-1861-2026 FDA Class II initiated 3 Mar 2026
    • Ongoing Z-1857-2026 FDA Class II initiated 3 Mar 2026
    • Ongoing Z-1868-2026 FDA Class II initiated 3 Mar 2026

    The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

  • 2 recalls, same reason

    • Ongoing Z-2453-2024 FDA Class II initiated 18 Jun 2024
    • Ongoing Z-2454-2024 FDA Class II initiated 18 Jun 2024

    Mislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however the inner pouch label may contain information for a different model (catheter length)

Specification

GUDID

Trade Name
Soft-Vu
Generic Name
Angiographic catheter, single-use
Model / Reference
10710049
Primary DI / UDI-DI
H787107100490
510(k) Number
FDA Product Code
DQO
GMDN Term
Angiographic catheter, single-use
Device Class
Class II
Regulation Number
870.1200
Commercial Distribution
Not in Commercial Distribution
Size
Catheter Gauge — 5 French
Outer Diameter — 1.8 Millimeter
Length — 40 Centimeter

Related devices

Cleared under the same submission (K173762)

Show all (12)

Other devices from Angiodynamics, Inc.

See all devices from Angiodynamics, Inc. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No