Recall Z-2377-2015 ยท DXE Catheter, Embolectomy
Boston Scientific Corporation
AngioJet Spiroflex Thrombectomy Set: Peripheral - UPN 106553-004, Catalog No.106553, Sterilized Using Ethylene Oxide. For breaking apart and removing thrombus from vascular system, used with the AngioJet Ultra System in breaking apart and removing thrombus from A-V access conduits.
| Date | Aug 13, 2015 (initiated Jul 31, 2015) |
| Status | Terminated |
| Reason | AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is Nov-2015, but the units are labeled with a use-by date of Dec-2015. |
| Root cause | Process control |
| Action | Boston Scientific sent an Urgent Medical Device Recall Removal letter dated July 31, 2015, to all affected consignees. The letter described the problem and the affected product. Consignees were advised to segregate the affected product and return it to Boston Scientific. They were also requested consignees to complete and return the Account Reply Verification Tracking Form. Contact your Sales Representative for any questions. For questions regarding this recall call 763-494-1556. |
| Quantity | total of 9 units |
| Distribution | Worldwide Distribution - US including AZ, MO, OH and Internationally to GERMANY and SPAIN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072769 | ANGIOJET ULTRA; XMI (105041), XVG (105042) AND SPIROFLEX (106553) THROMBECTOMY SETS Possis Medical, Inc., Nov 14, 2007 |