FDA Medical Device Recalls (openFDA)
Cook, Inc.: Cook ATB Advance PTA Dilatation Catheter, French size 5, rated burst pressure 15 atm, inflated diameter 7 mm, balloon length 4 cm, recommended introducer French size 6, sterile, REF (Global product no.) G26887, REF (order no.) ATB5-35-40-7-4.0.
- Recall number
- Z-0665-2007
- Recalling firm
- Cook, Inc.
- Product
- Cook ATB Advance PTA Dilatation Catheter, French size 5, rated burst pressure 15 atm, inflated diameter 7 mm, balloon length 4 cm, recommended introducer French size 6, sterile, REF (Global product no.) G26887, REF (order no.) ATB5-35-40-7-4.0.
- Status
- Terminated
- Initiated
- 2007-02-28
- Posted
- 2007-03-29
- Terminated
- 2007-05-29
- Reason
- Mislabeled as to size: The outer label reads 7-4.0 balloon, when the balloon is actually 5-2.0.
- Root cause
- Other
- Action
- Consignees were notified via telephone on 2/28/07 and instructed to return the product.
- Quantity
- 20 units
- Distribution
- Illinois, North Carolina and South Carolina.
- Lot, serial or model codes
- Lot 1820419.
- 510(k) numbers
- ["K052036"]
- PMA numbers
- not on file
- Product code
- DQY
- 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