Aq Hydrophilic Stent

• • Terminated Z-0977-2020 FDA Class II ·initiated 4 Jan 2019

  The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.

• • Terminated Z-0852-2011 FDA Unclassified (pre-2012) ·initiated 18 Oct 2010

  The firm received a customer complaint that a box labeled as Universa Firm Stents but the box actually contained Universa Soft Stents. The inner product label is correct but the outer box is wrong.

• • Terminated Z-0980-2009 FDA Unclassified (pre-2012) ·initiated 10 Nov 2008

  "Soft" stents were placed in "firm" stent outer boxes. The soft stent is only to be left in the patient for 6 months, but the firm stent can be left in the patient for 12 months, so this error could result in the stent being left in the patient for longer than indicated for the device.

• 15 recalls, same reason

  • Terminated Z-0839-2009 FDA Unclassified (pre-2012) ·initiated 31 Jul 2008
  • Terminated Z-0841-2009 FDA Unclassified (pre-2012) ·initiated 31 Jul 2008
  • Terminated Z-0850-2009 FDA Unclassified (pre-2012) ·initiated 31 Jul 2008
  • Terminated Z-0842-2009 FDA Unclassified (pre-2012) ·initiated 31 Jul 2008
  • Terminated Z-0844-2009 FDA Unclassified (pre-2012) ·initiated 31 Jul 2008
  • Terminated Z-0843-2009 FDA Unclassified (pre-2012) ·initiated 31 Jul 2008
  • Terminated Z-0845-2009 FDA Unclassified (pre-2012) ·initiated 31 Jul 2008
  • Terminated Z-0849-2009 FDA Unclassified (pre-2012) ·initiated 31 Jul 2008
  • Terminated Z-0846-2009 FDA Unclassified (pre-2012) ·initiated 31 Jul 2008
  • Terminated Z-0853-2009 FDA Unclassified (pre-2012) ·initiated 31 Jul 2008
  • Terminated Z-0851-2009 FDA Unclassified (pre-2012) ·initiated 31 Jul 2008
  • Terminated Z-0848-2009 FDA Unclassified (pre-2012) ·initiated 31 Jul 2008
  • Terminated Z-0847-2009 FDA Unclassified (pre-2012) ·initiated 31 Jul 2008
  • Terminated Z-0852-2009 FDA Unclassified (pre-2012) ·initiated 31 Jul 2008
  • Terminated Z-0840-2009 FDA Unclassified (pre-2012) ·initiated 31 Jul 2008

  The bond may break where the two materials meet, resulting in separation of the stent.

510(k) Number

K961446 ↗

FDA Product Code

FAD

Device Class

Class II

Regulation

21 CFR Part 876.4620

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• 3 Way Silicone Foley Balloon Catheter

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• Aq Hydrophilic Dilators

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• Bipolar Cutter

  Class II

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• Rutner Biopsy Device

  Class II

  FDA 510(k) K950810 Active Cleared 6 Mar 1995

• CO2 Pneumo-Dissector

  Class II

  FDA 510(k) K972647 Active Cleared 10 Apr 1998

• Pgd-Pre-Implantation Genetic Diagnostic Pipettes (Biopsy Pipettes)

  Class II

  FDA 510(k) K014160 Active Cleared 8 Feb 2002

See all devices from Cook Urological, Inc. →