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Terminated

Thoratec TLC-II Portable VAD Driver. Component (pneumatic) driver of Thoratec Ventricular Assist Device system

FDA Recall Z-1108-2007 · Posted 2007-07-27

Recalling FirmThoratec Corp
Recall StatusTerminated
Product CodeDSQ
Date Initiated2007-06-08
Date Terminated2008-07-17
Product Quantity378 drivers

Reason for Recall

Component Failure; Device Failure without warning; due to premature wear-out of the compressor motor, VAD support for the patient's circulatory system may fail without warning.

Firm Action

Urgent Medical Device Recall letters, dated June 08, 2007, were issued to consignees, with instructions to take the following actions: 1) check the current number of service hours on all units. 2) do not use TLC-II drivers exceeding 1500 hours until they are serviced by thoratec. 3) note the indicated hours on the product inventory form and return the form to Thoratec. 4) ensure that all patients have a back up driver and hand pumps at all times and have been trained in backup procedures. The firm is also arranging for the return and servicing of all affected drivers, with highest priority to those drivers already exceeding 1500 hours of life. A July 19, 2007, Press Release was issued by the firm.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide: USA including states of AL, AR, AZ, CA, CO, CT, FL, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, NY, OH, OR, PA, TN, TX, UT, VA, and WA, as well as, countries of Australia, Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Ireland, Israel, Italy, Netherlands, Qatar, Singapore, Switzerland, Taiwan, UAE, and UK.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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