Z-0280-06

Stainless Steel Greenfield Vena Cava Filter with 12 Fr / 4,0 mm FlexCarrier Capsule. For Femoral Vein...

Name: Z-0280-06 Stainless Steel Greenfield Vena Cava Filter with 12 Fr / 4,0 mm FlexCarrier Capsule. For Femoral Vein...
Creator: Boston Scientific
Published: 2005-12-02
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2005-12-02 / Terminated / root cause: manufacturing process

FDA source

Boston Scientific began a recall of 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... on 2005-12-02. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0280-06
Status: Terminated
Initiated: 2005-12-02
Posted: 2005-12-20
Terminated: 2007-04-02
Recalling firm: Boston Scientific Corporation
Product: 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 & Technology Park, Model Farm Road, Cork, Ireland. The Stainless Steel Greenfield Vena Cava Filter with 12 Fr. / 4,0 mm introducer System is a permanently implanted stainless steel device designed to protect against pulmonary embolism while maintaining patency of the inferior vena cava. The Stainless Steel Greenfield Vena Cava Filter comes preloaded in a 12 Fr. / 4,0 mm jugular or femoral introducer catheter.
Product code: DTK Filter, Intravascular, Cardiovascular
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 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, Lebanon, Mexico, Malaysia, Netherlands, New Zealand, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, South Africa, Thailand, Trinidad and Tobago, Taiwan, Venezuela
Product codes and lots: all codes of product manufactured before March 10, 2004. Catalog no. 50-501 with lot/batch # between 5145758 and 6387904

Product code DTK

K964284Class IIStainless Steel Greenfield Vena Cava Filter with 12F Introducer SystemBoston Scientific Corp / cleared 1997-01-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)