Venous Return Catheter Ss-1

• 2 recalls, same reason

  • Terminated Z-0812-2012 FDA Unclassified (pre-2012) ·initiated 14 Dec 2011
  • Terminated Z-0808-2012 FDA Unclassified (pre-2012) ·initiated 14 Dec 2011

  Instructions for Use for the DLP Single Stage Venous Cannulae are in the process of being updated. The current precaution statement referencing ventricular assist procedures will be identified as a contraindication in the updated Instructions for Use. DO NOT USE THIS PRODUCT FOR EXTENDED TERMS SUCH AS VENTRICULAR ASSIST PROCEDURES. Medtronic has received two reports of patient deaths due to p

• • Terminated Z-1489-04 FDA Unclassified (pre-2012) ·initiated 15 Sep 2004

  Spiral tip from DLP VAD cannula may be loose and potentially detach during use.

510(k) Number

K845045 ↗

FDA Product Code

DWF

Device Class

Class II

Regulation

21 CFR Part 870.4210

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Infant Vent Catheter 12001 W/Side Vent Open recall

  Class II

  FDA 510(k) K834039 Active Cleared 3 Jan 1984

• Submission Coronary Cannula

  Class II

  FDA 510(k) K821149 Active Cleared 18 May 1982

• Percutaneous Guidewire Placement Syringe 50505

  Class II

  FDA 510(k) K855089 Active Cleared 18 Feb 1986

• Clearview Blower/Mister Open recall

  Class II

  FDA 510(k) K973485 Active Cleared 8 Dec 1997

• Dispossable Suction Tube, 6 French

  Class II

  FDA 510(k) K791846 Active Cleared 2 Oct 1979

• Aortic Root Cannula W/Integral Press

  Class II

  FDA 510(k) K831591 Active Cleared 30 Jun 1983

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