Thoratec Ventricular Assist Device (VAD) System

• • Terminated Z-1109-2007 FDA Unclassified (pre-2012) ·initiated 30 Mar 2007

  Incorrect collect nut assembly (inadvertent use of the incorrect (Black) collect nut) during surgical implantation (wrong size collect nut) to secure the inflow cannula to the PVAD has resulted in patient deaths

• • Terminated Z-0412-2007 FDA Unclassified (pre-2012) ·initiated 24 Sep 2004

  The module power switch (at the back of console) may break while attempting to turn the Dual Drive Console OFF or ON.

• • Terminated Z-0015-2007 FDA Unclassified (pre-2012) ·initiated 26 Jan 2004

  During use an unexpected flaking of the inner surface coating (blood contact) that has the potential for risk of embolism.

Full name

Thoratec Implantable Ventricular Assist Device

Trade Name

Thoratec(R) Ventricular Assist Device (Vad) System

Generic Name

Ventricular (assist) bypass

PMA Number

P870072 ↗

FDA Product Code

DSQ

Device Class

Class III

Advisory Committee

Cardiovascular

FDA Decision

APWD Approval withdrawn

• Respiratory Circuit Adaptor

  Class I

  FDA 510(k) K823287 Active Cleared 9 Dec 1982

• Respiratory Gas Analyzer

  Class II

  FDA 510(k) K823449 Active Cleared 5 Jan 1983

• Thoratec Gas Sampling Connector

  Class I

  FDA 510(k) K822769 Active Cleared 6 Oct 1982

• Thoratec Multilumen Central Venous Cath-Tray

  Not classified

  FDA 510(k) K851495 Active Cleared 1 Aug 1985

• Vascular Graft Tunneler-Standard Curve, Mid Curve, Full Curve, Short Standard Curve, Vascular Graft Tunneler Accessories

  Class II

  FDA 510(k) K001926 Active Cleared 22 Sep 2000

• Impco Disposable Aortic Punch

  Class I

  FDA 510(k) K780247 Active Cleared 27 Feb 1978

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