Easytrak Guiding Catheter

• 17 recalls, same reason

  • Terminated Z-0792-04 FDA Unclassified (pre-2012) ·initiated 11 Mar 2004 ·on shared 510(k) K021284
  • Terminated Z-0796-04 FDA Unclassified (pre-2012) ·initiated 11 Mar 2004 ·on shared 510(k) K021284
  • Terminated Z-0794-04 FDA Unclassified (pre-2012) ·initiated 11 Mar 2004 ·on shared 510(k) K021284
  • Terminated Z-0799-04 FDA Unclassified (pre-2012) ·initiated 11 Mar 2004 ·on shared 510(k) K021284
  • Terminated Z-0804-04 FDA Unclassified (pre-2012) ·initiated 11 Mar 2004 ·on shared 510(k) K021284
  • Terminated Z-0801-04 FDA Unclassified (pre-2012) ·initiated 11 Mar 2004 ·on shared 510(k) K021284
  • Terminated Z-0793-04 FDA Unclassified (pre-2012) ·initiated 11 Mar 2004 ·on shared 510(k) K021284
  • Terminated Z-0797-04 FDA Unclassified (pre-2012) ·initiated 11 Mar 2004 ·on shared 510(k) K021284
  • Terminated Z-0803-04 FDA Unclassified (pre-2012) ·initiated 11 Mar 2004 ·on shared 510(k) K021284
  • Terminated Z-0798-04 FDA Unclassified (pre-2012) ·initiated 11 Mar 2004 ·on shared 510(k) K021284
  • Terminated Z-0790-04 FDA Unclassified (pre-2012) ·initiated 11 Mar 2004 ·on shared 510(k) K021284
  • Terminated Z-0791-04 FDA Unclassified (pre-2012) ·initiated 11 Mar 2004 ·on shared 510(k) K021284
  • Terminated Z-0800-04 FDA Unclassified (pre-2012) ·initiated 11 Mar 2004 ·on shared 510(k) K021284
  • Terminated Z-0802-04 FDA Unclassified (pre-2012) ·initiated 11 Mar 2004 ·on shared 510(k) K021284
  • Terminated Z-0805-04 FDA Unclassified (pre-2012) ·initiated 11 Mar 2004 ·on shared 510(k) K021284
  • Terminated Z-0806-04 FDA Unclassified (pre-2012) ·initiated 11 Mar 2004 ·on shared 510(k) K021284
  • Terminated Z-0795-04 FDA Unclassified (pre-2012) ·initiated 11 Mar 2004 ·on shared 510(k) K021284

  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

K021284 ↗

FDA Product Code

DQY

Device Class

Class II

Regulation

21 CFR Part 870.1250

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Guidant Corp. →