AngioDynamics 06597018

• • Terminated Z-0418-2021 FDA Class II ·initiated 14 Oct 2020

  5F Micro-Introducer Kits may not contain the correct device, packaged with a 4F Sheath/Dilator component

• 7 recalls, same reason

  • Terminated Z-0777-2017 FDA Class II ·initiated 28 Sep 2016
  • Terminated Z-0776-2017 FDA Class III ·initiated 28 Sep 2016
  • Terminated Z-0778-2017 FDA Class III ·initiated 28 Sep 2016
  • Terminated Z-0774-2017 FDA Class III ·initiated 28 Sep 2016
  • Terminated Z-0775-2017 FDA Class III ·initiated 28 Sep 2016
  • Terminated Z-0773-2017 FDA Class III ·initiated 28 Sep 2016
  • Terminated Z-0772-2017 FDA Class III ·initiated 28 Sep 2016

  Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotating luer to detach from the dilator hub during use. AngioDynamics has confirmed that affected sheath/dilators (Greatbatch Model Numbers 10904-001 and 10904-002) have been included in packaged AngioDynamics Stiffened Micro-Introducer Kits.

• • Terminated Z-1405-2013 FDA Class II ·initiated 30 Apr 2013

  AngioDynamics Inc., is recalling Micro Introducer Kits and VenaCure EVLT NeverTouch Procedure Kits, because the potential exists that the micro Introducer (sheath/dilator) packaged within the kit could be the incorrect French size.

Trade name

AngioDynamics

Generic name

Vascular catheter introduction set, nonimplantable

Model / reference

06597018

Primary DI / UDI-DI

H787065970180

510(k) Number

K051655 ↗

FDA product code

DQR, DQX, DYB, DRC

GMDN term

Vascular catheter introduction set, nonimplantable

Device class

Class II

Regulation number

870.1300, 870.1330, 870.1340, 870.1390

GUDID distribution status

In Commercial Distribution

Size

Catheter Gauge — 5 French

Category: Vascular catheter introduction set, nonimplantable

• AngioDynamics H787TDST0

  Class I

  GUDID on market

• AngioDynamics H787065200010

  Class II

  FDA 510(k) K013871 Active Cleared 29 Mar 2002 GUDID on market

• NanoKnife H78720300301US0 Open recall

  Class II

  FDA 510(k) ×2 Active Cleared 18 Jun 2019 GUDID on market

• NanoKnife H787204001090 Open recall

  Class II

  FDA 510(k) ×2 Active Cleared 18 Jun 2019 GUDID on market

• NanoKnife H787204003010 Open recall

  Class II

  FDA 510(k) ×3 Active Cleared 18 Jun 2015 GUDID on market

• NanoKnife H787204001100 Open recall

  Class II

  FDA 510(k) ×2 Active Cleared 18 Jun 2019 GUDID on market

See all devices from Angiodynamics, Inc. →