Recall Z-0212-2008 ยท DSQ Ventricular (Assist) Bypass
Thoratec Corp
Thoratec Implantable Ventricular Assist Device (IVAD pump) (Component of Thoratec Ventricular Assist Device (VAD) System), Catalog No. 10012-2555-001 ,Thoratec Corporation, Pleasanton, CA. 94588
| Date | Nov 21, 2007 (initiated Oct 19, 2007) |
| Status | Terminated |
| Reason | Pneumatic Leaks: air leaks developing in the pneumatic driveline when subjected to excessive stress at the junction of the percutaneous line to the pump housing due to sharp bending when implanted (paracorporeal-external-position). |
| Root cause | Device Design |
| Action | An initial communication was sent to all affected IVAD customers on October 19, 2007, in the form of an "Urgent: Medical Device Correction" notice informing them of the problem. The correction notice requests that its customers/physicians take the following actions: 1) Contact all ongoing patients with IVADs placed in the paracorporeal position to evaluate the percutaneous line adjacent to the pump housing to ensure that it is not subject to extreme flexing or bending at acute angles. 2) Remind implanting surgeons and support staff of proper percutaneous line management and provide the patient |
| Quantity | 766 |
| Distribution | Worldwide: USA including states of AL,AR,AZ,CA,CO, FL,GA, IA,IL, IN,KS,KY,LA, MA, MD, ME,MI, MN, MO,NC, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI and to the following countries: Austria, Canada, France, Netherlands, Singapore, Switzerland, and The United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.