Recall Z-0889-2011 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Cardiac Assist, Inc
TandemHeart Transseptal Cannulas-EF set (THTC-EF) - Dilator assembly The TandemHeart Transseptal Cannula Set-EF is intended for transseptal catheterization of the left atrium via the femoral vein for the purpose of providing a means for temporary (six hours or less) left ventricular bypass when connected to the TandemHeart extracorporeal blood pump which returns blood to the patient via the femora
| Date | Jan 10, 2011 (initiated Dec 2, 2010) |
| Status | Terminated |
| Reason | Component (Dilator of TandemHeart Transseptal Cannula Set-EF) does not meet specifications |
| Root cause | Other |
| Action | CardiacAssist, Inc. sent a Voluntary Recall letter dated November 12, 2010, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignees. Consignees were instructed to examine inventory for the affected product and remove from inventory and identify it as a recalled product by applying the enclosed "CAUTION: DO NOT USE" sticker(s) and quarantine to prevent usage. Consignees were to complete the form included with the letter and fax a copy of the form to (412) 963-9739 to coordinate the return and replacement of any affected product |
| Quantity | 164 |
| Distribution | Nationwide distribution including AZ, CA, CO, CT, DC, FL, GA, IL, LA, MA, MD, MI, MN, NC, NH, NJ, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052570 | TANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-6221 Cardiacassist, Inc., Jan 17, 2006 |