Events

Recall of THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Thoratec Corp.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    50091
  • Event Risk Class
    Class 2
  • Event Number
    Z-0496-2009
  • Event Initiated Date
    2008-10-24
  • Event Date Posted
    2008-12-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-01-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74710
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Ventricular (assist) bypass - Product Code DSQ
  • Reason
    The firm has become aware that, over time, wear and fatigue of the percutaneous lead connecting the heartmate ii left ventricular assist system (hm ii lvas) blood pump with external system controller may result in damage that has the potential to interrupt pump function and may require a reoperation to replace the pump.
  • Action
    An initial "Urgent: Medical Device Correction" letter dated October 21, 2008 and a follow-up letter dated October 24, 2008 were sent to affected HeartMate II Left Ventricular Assist System (HM II LVAS) customers. The letters identified the problem, immediate action and preventive action to be taken by customers and recommended that the pump be replaced as soon as possible if damage to the percutaneous lead is confirmed. If customers suspect that a HM II LVAS patient may have a damaged percutaneous lead, please contact Thoratec Technical Services (800-456-1477) for assistance. A return response (Acknowledgement Form) was included with the letter for consignees to complete and fax it to Thoratec Regulatory Affairs at 925-847-8628. Direct questions to the Thoratec Regulatory Affairs Department at 925-730-4135 (Monday-Friday, 8 a.m.-5 p.m. PST). Clinicians and patients with questions may contact the firm at 800-528-2577, or if calling outside the USA, 925-847-8600 (7 days a week, 8 a.m.-5 p.m. PST). Copies of the press release may be found on the firm's website, www.thoratec.com, under Investor Relations/Press Releases.

Device

THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM
  • Model / Serial
    All serial numbers.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution.
  • Product Description
    Thoratec Heartmate II Left Ventricular Assist System (LVAS). Model/Catalog Number 1355 and Model/Catalog Number 102139. || Product is manufactured and distributed by Thoratec Corporation, || Pleasant, CA. || The HM II LVAS is intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; either for temporary support, such as a bridge to cardiac transplantation or myocardial recovery, or as permanent destination therapy. The HeartMate II is intended for use inside or outside the hospital.
  • Manufacturer
    Thoratec Corp

Manufacturer

Thoratec Corp
  • Manufacturer Address
    Thoratec Corp, 6035 Stoneridge Drive, Pleasanton CA 94588
  • Source
    USFDA