Recall Z-0757-2013
Abbott Vascular · initiated November 30, 2011
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Lot Number: 1081061, 1082561, 1091361, 1080561, 1081761, 1090261, 1091561, 1100461, 1080361, 1081661, 1090161, 1090861, 1092361, 1080861, 1082661, 1100761, 1081761, 1092861, 1082461, 1081161, 1082261, 1083061, 1081961, 1093061.
Reason for recall
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-0757-2013
- Initiated
- November 30, 2011
- Posted by FDA
- January 31, 2013
- Terminated
- January 31, 2013
- Product code
- NTE – Temporary Carotid Catheter For Embolic Capture
- 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.
- Recalling firm
- Abbott Vascular, Temecula, CA