Recall Z-1108-2007 ยท DSQ Ventricular (Assist) Bypass
Thoratec Corp
Thoratec TLC-II Portable VAD Driver. Component (pneumatic) driver of Thoratec Ventricular Assist Device system
| Date | Jul 27, 2007 (initiated Jun 8, 2007) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| 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 prior |
| Quantity | 378 drivers |
| Distribution | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.