Medtronic 5F & 9F Zuma Guiding Catheters

• • Terminated Z-2754-2011 FDA Unclassified (pre-2012) ·initiated 8 Jun 2011

  Mislabeled; Product labeled as 6F Zuma Guide with AL 1.5 curve with side holes may contain a 5F Zuma Catheter with SAL 1.0 curve

• 4 recalls, same reason

  • Terminated Z-1056-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-1054-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-1057-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006
  • Terminated Z-1055-06 FDA Unclassified (pre-2012) ·initiated 5 Apr 2006

  Potential for non-sterility due to loss of package integrity

510(k) Number

K990707 ↗

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 →