Recall Z-2766-2015 ยท NGV System, Appendage Closure, Left Atrial
Boston Scientific Corporation
Boston Scientific, WATCHMAN Access System Access Sheath with Dilator, 14F Single curve( M635TU10060, TU1006) , 14F Double curve (M635TU20060, TU2006) , & 14F Anterior curve (M635TU40060, TU4006). For cardiac use.
| Date | Aug 25, 2015 |
| Status | Terminated |
| Reason | Cross-threading of the hemostasis valve may occur if it is tightened with the dilator in place, possibly preventing subsequent sealing of the valve when desired. This Field Correction reinforces the Directions for Use (DFU) and gives further guidance on correct use of the hemostasis valve to avoid cross-threading and to securely seal the valve, minimizing potential for undesired blood leakage. |
| Root cause | Use error |
| Action | Consignees were sent a Boston Scientific "Urgent Field Correction" letter dated August 25, 2015. The letter was addressed to Materials manager / Field Action Contact. The letter described the problem and the product affected. The Field Correction reinforces existing Directions for USE (DFU) and provides further guidance regarding the correct us of the hemostatis valve in order to avoid cross-threading and to securely seal the valve, minimizing the poential for undesirable blood leakage. The consignees were informed of the action required which stated that no product is required to be returned |
| Quantity | 29,169 units total |
| Distribution | Worldwide Distribution-US (nationwide) and the countries of Argentina, Australia, Austria, Belgium, Canada, Chile, China, Colombia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Great Britain, Greece, Hong Kong, Hungary, Indonesia, Iran, Ireland, Israel, Italy, Kazakhstan, Kuwa |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.