Stainless Steel Greenfield Vena Cava Filter with 12 Fr / 4,0 mm FlexCarrier Capsule. For Femoral Vein Introduction Only.
FDA device recall Z-0280-06 · posted 2005-12-20 · Terminated
Recall details
- Recalling firm
- Boston Scientific
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DTK
- Quantity affected
- 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,
- Date initiated
- 2005-12-02
- Date posted
- 2005-12-20
- Date terminated
- 2007-04-02
- Location
- Maple Grove, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F INTRODUCER SYSTEM (K964284) | Boston Scientific Corp | 1997-01-06 |