Recall Z-1228-2012 ยท DSQ Ventricular (Assist) Bypass
Thoratec Corporation
HeartMate II Left Ventricular Assist System (HM II LVAS) Sealed Outflow Graft Bend Relief. The Sealed Outflow Graft Bend Relief is provided as a component of the HM II Sealed Outflow Graft, which in turn is a component of the HM II LVAS Implant Kit with Sealed Grafts. A short configuration of the HM II LVAS Sealed Outflow Graft Bend Relief is provided as a stand-along product. Thoratec Corporati
| Date | Mar 23, 2012 (initiated Feb 23, 2012) |
| Status | Terminated |
| Reason | A trend of disconnected bend reliefs on the sealed outflow graft used with the HeartMate II LVAS has been identified |
| Root cause | Device Design |
| Action | Thoractec Corporation sent an Urgent Medical Device Correction letter on February 23, 2012 via overnight courier and e-mail to all affected consignees. The Urgent Medical Device Correction notification letters identify the affected products, description of the problem with illustrations, symptoms of problem and immediate actions to taken. All users are asked to review the attached labeling, including new caution statements and share with all surgical personnel. Consignees are instructed to completed and returned the Acknowledgement Form indicating that the information was received and under |
| Quantity | 3852 units in commerce |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of: Austria, Belgium, Denmark, Germany, Greece, France, Hong Kong, Kuwait, Ireland, Israel, Italy, Lebanon, Liechtenstein, Lithuania, Luxembourg, Malaysia, Netherlands, Turkey, Saudi Arabia, Singapore, Slovenia, Spain, Sweden, Switzerla |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.