Recall Z-0280-06 ยท DTK Filter, Intravascular, Cardiovascular
Boston Scientific
Stainless Steel Greenfield Vena Cava Filter with 12 Fr / 4,0 mm FlexCarrier Capsule. For Femoral Vein Introduction Only. Order No. 50-501. Sterile EO. Single Use Only. Read Instructions for Use before using this device. Distributed in USA by: Boston Scientific Corporation, One Boston Scientific Place, Natick, MA USA 01760. Manufacturer: Boston Scientific Cork Ltd., Business & Technolog
| Date | Dec 20, 2005 (initiated Dec 2, 2005) |
| Status | Terminated |
| Reason | There have been reports of detachment at the bond between the carrier capsule and the outer sheath of the Greenfield Vena Cava Filters with 12 Fr Femoral introducer Systems manufactured before Marcyh 10, 2004. If the capsule should detach during an implantation procedure, there is a risk of cardiac and pulmonary embolization. |
| Root cause | Other |
| Action | Recall packages started going out 12/02/05 via Fed Ex and was completed 12/03/05. A letter was directed to several persons within each hospital . The letter describes the issues, the affected lot numbers and the complaints that Boston Scientific has received. Affected devices are to be segregated for return back to Boston Scientific. A 'Reply Verification Tracking Form' is asked to be returned back to Boston Scientific. |
| Quantity | 18,000 |
| Distribution | nationwide (except ND); Virgin Islands, OUS to include: united Arab Emirates, Argentina, Australia, Belgium, Brunei Darussalam, Brazil, Canada, Chile, China, Colombia, Germany, Spain, France, Ireland, Great Britain, Israel, India, Italy, Jamaica, Jordan, Japan, Korea (South Republic), Kuwait, Le |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964284 | STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F INTRODUCER SYSTEM Boston Scientific Corp, Jan 6, 1997 |