FDA Medical Device Recalls (openFDA)
Cordis Corporation: Product is a Powerflex P3 Dialation Catheter. Product is labeled in part: ''***POWERFLEX P3***Cordis***a Johnson and Johnson company***ENDOVASCULAR***STERILE EO***Cordis Europa N.V., 9301 LJ Roden, The Netherlands***''
- Recall number
- Z-1556-05
- Recalling firm
- Cordis Corporation
- Product
- Product is a Powerflex P3 Dialation Catheter. Product is labeled in part: ''***POWERFLEX P3***Cordis***a Johnson and Johnson company***ENDOVASCULAR***STERILE EO***Cordis Europa N.V., 9301 LJ Roden, The Netherlands***''
- Status
- Terminated
- Initiated
- 2005-05-11
- Posted
- 2005-09-21
- Terminated
- 2008-11-20
- Reason
- During competitive product testing, wire movement difficulties were observed in Powerflex P3 units. Due to the possibility of user inconvenience, Cordis is recalling the six affected lots of Powerflex P3. There is no patient impact.
- Root cause
- Other
- Action
- Recalled by letter and Cordis Sales Representatives interfacing directly with US consignees.
- Quantity
- 48 units
- Distribution
- Distributed to 35 consignees throughout the US and other consignees in 11 countries worldwide.
- Lot, serial or model codes
- Lot numbers R0305581, R0305159, R0305284, R0305286, R0305155 and R0305104.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LIT
- Firm FEI
- 1016427
- Firm city
- Miami Lakes
- Firm state
- FL
- 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