Recall Z-0338-2011 ยท NIM Stent, Carotid
Abbott Vascular
RX ACCULINK Carotid Stent System 10 X 20mm, Part Number: 1011342-20, Lot Number: 0072061 The RX Acculink Carotid Stent System, used in conjunction with Abbott Vascular RX Accunet embolic protection system, is indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the criteria outlined below. (1) Patients wi
| Date | Nov 10, 2010 (initiated Sep 10, 2010) |
| Status | Terminated |
| Reason | The recall was initiated because Abbott vascular has discovered through internal testing that the affected lots may not meet the firm's quality specifications for catheter shaft tensile strength. If the affected device is used it may result in acute stent deployment difficulties and subsequent intervention. |
| Root cause | Pending |
| Action | Abbott Vascular sent an URGENT DEVICE RECALL letter dated September 10, 2010, to all consignees. The letter identified the product, the problem, and the action to be taken. The Sales Representatives were to personally visit each account to deliver the recall letter and assist in identifying and returning any unused devices to Abbott Vascular. Also, Abbott Vascular Regulatory Compliance initiated contact with the Risk Management department at each account by phone to verify their mailing address and provide a courtesy copy of the recall letter. The consignees were instructed to work with th |
| Quantity | 42 units total for all products |
| Distribution | Nationwide Distribution including AL, CA, CT, DC, FL, GA, IA, IL, IN, MA, ME, MI, MN, MO, OH, OK PA, TX, VA, and WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.