Rapido Guiding Catheter, 6F Model# 6776; Rapido Guiding Catheter, 8F Model# 6775, 6777, 6778, 6779, 6780, 6781, 6782,

• • Terminated Z-2793-2011 FDA Unclassified (pre-2012) ·initiated 7 Jan 2011

  Five lots of Guide Catheters and Accessory products were processed through Ethylene Oxide (ETO) sterilization with additional plastic material covering the pallet, which is not consistent with validated packaging configuration for ETO sterilization.

• 17 recalls, same reason

  • Terminated Z-0792-04 FDA Unclassified (pre-2012) ·initiated 11 Mar 2004 ·on shared 510(k) K021455
  • Terminated Z-0796-04 FDA Unclassified (pre-2012) ·initiated 11 Mar 2004 ·on shared 510(k) K021455
  • Terminated Z-0794-04 FDA Unclassified (pre-2012) ·initiated 11 Mar 2004 ·on shared 510(k) K021455
  • Terminated Z-0799-04 FDA Unclassified (pre-2012) ·initiated 11 Mar 2004 ·on shared 510(k) K021455
  • Terminated Z-0804-04 FDA Unclassified (pre-2012) ·initiated 11 Mar 2004 ·on shared 510(k) K021455
  • Terminated Z-0801-04 FDA Unclassified (pre-2012) ·initiated 11 Mar 2004 ·on shared 510(k) K021455
  • Terminated Z-0793-04 FDA Unclassified (pre-2012) ·initiated 11 Mar 2004 ·on shared 510(k) K021455
  • Terminated Z-0797-04 FDA Unclassified (pre-2012) ·initiated 11 Mar 2004 ·on shared 510(k) K021455
  • Terminated Z-0803-04 FDA Unclassified (pre-2012) ·initiated 11 Mar 2004 ·on shared 510(k) K021455
  • Terminated Z-0798-04 FDA Unclassified (pre-2012) ·initiated 11 Mar 2004 ·on shared 510(k) K021455
  • Terminated Z-0790-04 FDA Unclassified (pre-2012) ·initiated 11 Mar 2004 ·on shared 510(k) K021455
  • Terminated Z-0791-04 FDA Unclassified (pre-2012) ·initiated 11 Mar 2004 ·on shared 510(k) K021455
  • Terminated Z-0800-04 FDA Unclassified (pre-2012) ·initiated 11 Mar 2004 ·on shared 510(k) K021455
  • Terminated Z-0802-04 FDA Unclassified (pre-2012) ·initiated 11 Mar 2004 ·on shared 510(k) K021455
  • Terminated Z-0805-04 FDA Unclassified (pre-2012) ·initiated 11 Mar 2004 ·on shared 510(k) K021455
  • Terminated Z-0806-04 FDA Unclassified (pre-2012) ·initiated 11 Mar 2004 ·on shared 510(k) K021455
  • Terminated Z-0795-04 FDA Unclassified (pre-2012) ·initiated 11 Mar 2004 ·on shared 510(k) K021455

  The terminal hub component in a some of the catheters has an unintended abrupt transition between the entry port and the catheter lumen which can result in difficulty introducing or removing delivery system components during lead placement.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K021455 ↗

FDA Product Code

DQY

Models / Variants

Rapido Guiding Catheter, 6F Model# 6776

Rapido Guiding Catheter, 8F Model# 6775, 6777, 6778, 6779, 6780, 6781, 6782,

Device Class

Class II

Regulation

21 CFR Part 870.1250

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Acuity Steerable Stylet Accessory

  Class II

  FDA 510(k) K053019 Active Cleared 3 Mar 2006

• Rapido Cut-Away Bleedback Control Valve (Bbcv), Model 7568

  Class II

  FDA 510(k) K031903 Active Cleared 3 Mar 2004

• Modification to Rx Herculink 14 Biliary Stent System, Models 1005126-13, 1005128-13, 1005130-13, 1005132-13, 1005134-13,

  Class II

  FDA 510(k) K993588 Active Cleared 17 Nov 1999

• Hi-Torque Balance Iniversal Guide Wire with Hydrocoat Hydrophilic Coating

  Class II

  FDA 510(k) K031678 Active Cleared 26 Aug 2003

• ACS Hi-Torque Cross IT 100XT, 200XT, and 300XT Guide Wires with Hydrocoat Hydrophilic Coating

  Class II

  FDA 510(k) K990639 Active Cleared 25 Mar 1999

• Guidant Vasoview Hemopro Endoscopic Vessel Harvesting System, Model Vh-3000 Open recall

  Class II

  FDA 510(k) K052274 Active Cleared 21 Sep 2005

See all devices from Guidant Corp. →