FDA Medical Device Recalls (openFDA)
Cook, Inc.: Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 28mm, B=155mm, C=125mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-28-125.
- Recall number
- Z-0519-05
- Recalling firm
- Cook, Inc.
- Product
- Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 28mm, B=155mm, C=125mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-28-125.
- Status
- Terminated
- Initiated
- 2004-12-20
- Posted
- 2005-02-03
- Terminated
- 2005-12-02
- Reason
- The firm has received complaints of difficulty in releasing the barbed suprarenal stent from the top cap that constrains it, which may result in misplacement of the graft.
- Root cause
- Other
- Action
- Recall letter dated 12/20/04 was issued to each consignee via FedEx instructing them to cease using the products and to return them to the firm.
- Quantity
- not on file
- Distribution
- Nationwide and Canada.
- Lot, serial or model codes
- All units distributed on or before 12/17/04.
- 510(k) numbers
- not on file
- PMA numbers
- ["P020018"]
- Product code
- MIH
- Firm FEI
- 1820334
- Firm city
- Bloomington
- Firm state
- IN
- 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