FDA Medical Device Recalls (openFDA)
Guidant Corp-Cpi Division: Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Length 54 cm, Coronary Sinus - Multi-Purpose Long Tip Shape, CS-MPL, REF 7507
- Recall number
- Z-0801-04
- Recalling firm
- Guidant Corp-Cpi Division
- Product
- Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Length 54 cm, Coronary Sinus - Multi-Purpose Long Tip Shape, CS-MPL, REF 7507
- Status
- Terminated
- Initiated
- 2004-03-11
- Posted
- 2004-07-20
- Terminated
- 2005-10-31
- Reason
- The terminal hub component in a some of the catheters has an unintended abrupt transition between the entry port and the catheter lumen which can result in difficulty introducing or removing delivery system components during lead placement.
- Root cause
- Other
- Action
- Starting on March 11, 2003, the firm''s representatives visited consignees, to whom the recalled catheters had been consigned, and retrieved the catheters.
- Quantity
- 20 catheters
- Distribution
- Nationwide in the United States.
- Lot, serial or model codes
- Lots 4020551, 4021151, 4021251, and 4022551
- 510(k) numbers
- ["K021284","K021455"]
- PMA numbers
- not on file
- Product code
- DQR
- Firm FEI
- 2124215
- Firm city
- Saint Paul
- Firm state
- MN
- 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