Medtronic Zuma Guiding Catheter

• 23 recalls, same reason

  • Terminated Z-1068-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-1069-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-1076-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-1065-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-1011-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-1067-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-1074-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-1058-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-1059-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-1013-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-1061-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-1063-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-1010-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-1062-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-1075-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-1073-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-1070-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-1060-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-1012-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-1066-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-1071-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-1064-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-1072-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006

  Potential for non-sterility due to loss of package integrity

• 2 recalls, same reason

  • Terminated Z-0799-03 FDA Unclassified (pre-2012) ·initiated 17 Mar 2003 ·on shared 510(k) K981198
  • Terminated Z-0800-03 FDA Unclassified (pre-2012) ·initiated 17 Mar 2003 ·on shared 510(k) K981198

  The PTCA catheter is mislabeled: the curve style (Judkin Left vs. Judkin Right ) of the catheter may not correctly match the box label.

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

510(k) Number

K981198 ↗

FDA Product Code

DQY

Device Class

Class II

Regulation

21 CFR Part 870.1250

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Gc IV Coronary Guiding Catheter

  Class II

  FDA 510(k) K932933 Active Cleared 1 Feb 1994

• Medtronic 7F and 8F Zuma Guiding Catheter

  Class II

  FDA 510(k) K982883 Active Cleared 4 Sep 1998

• Medtronic Interventional Vascular Y-Adapter, Tri-Adapter, Tri-Adapter & Accessory Packs

  Class II

  FDA 510(k) K940063 Active Cleared 29 Mar 1994

• Medtronic(R) 8.2 French Sherpa(R) Super Peak Flow(Tm) Coronary Guiding Catheter

  Class II

  FDA 510(k) K950026 Active Cleared 5 Apr 1995

• Sherpa Sherpa II and Ascent Coronary Guiding Catheters

  Class II

  FDA 510(k) K944668 Active Cleared 3 Mar 1995

• Medtronic Gciii Coronary Guiding Catheter

  Class II

  FDA 510(k) K935738 Active Cleared 4 May 1994

See all devices from Medtronics Interventional Vascular →