Recall Z-0757-2013 ยท NTE Temporary Carotid Catheter For Embolic Capture
Abbott Vascular
Brand Name: RX Accunet Embolic Protection System Common Name: RX Accunet EPS. Part Numbers: 101649-45, 1011649-55, 1011649-65, 1011649-75, 1011650-55, 1011650-65, 1011651-45, 1011651-55. The RX Accunet EPS is indicated for use as a guide wire and embolic protection system.
| Date | Jan 31, 2013 (initiated Nov 30, 2011) |
| Status | Terminated |
| Reason | The recall was initiated because Abbot Vascular has discovered that the identified lots of the RX Accunet Embolic Protection System may exhibit difficult removal of the peel away sheath due to higher than normal wall thickness. |
| Root cause | Nonconforming Material/Component |
| Action | Abbott Vascular sent an "URGENT DEVICE RECALL" letter dated November 30, 2011 to all affected customers. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to work with their local account representative to review their inventory, complete the attached Field Action Reconciliation/ Effectiveness Check Form and return any unused identified products to Abbott Vascular. |
| Quantity | 1253 units (962 units in the US & Puerto Rico) |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Austria, Belgium, China, Germany, Spain, France, United Kingdom, Italy, Pakistan, Poland, Russia, Slovakia, Taiwan, and South Africa. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081549 | RX ACCUNET LP EMBOLIC PROTECTION SYSTEM Abbott Laboratories, Aug 19, 2008 |