FDA Medical Device Recalls (openFDA)
Bard Peripheral Vascular Inc: Recovery G2 Filter System - Jugular/Subclavian Delivery Kit, for use in the prevention of recurrent pulmonary embolism. Catalog Number RF-220J ***For Canada & Australia only***
- Recall number
- Z-0394-2007
- Recalling firm
- Bard Peripheral Vascular Inc
- Product
- Recovery G2 Filter System - Jugular/Subclavian Delivery Kit, for use in the prevention of recurrent pulmonary embolism. Catalog Number RF-220J ***For Canada & Australia only***
- Status
- Terminated
- Initiated
- 2006-12-20
- Posted
- 2007-02-01
- Terminated
- 2008-10-23
- Reason
- This action is being taken because BPV has recently received three complaints for the device that involve reports of introducer sheath tip damage. The damage may result in loss of tip integrity.
- Root cause
- Other
- Action
- Recall letters were sent to all consignees via Federal Express overnight delivery with signature receipt required on December 20, 2006. Each letter included a Recall and Effectiveness Check Form for each consignee to fill out and fax to Bard Peripheral Vascular, Inc (BPV). Customers will be asked to immediately remove product from inventory and isolated from use and contact BARD for return authorization. All returned product will be destroyed.
- Quantity
- 124 units
- Distribution
- Worldwide including USA, Australia, and Canada
- Lot, serial or model codes
- Lot numbers: GFPK3279, GFPK3280, GFPK3281 & GFPK3282
- 510(k) numbers
- ["K052578"]
- PMA numbers
- not on file
- Product code
- DTK
- Firm FEI
- 2020394
- Firm city
- Tempe
- Firm state
- AZ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28