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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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***''
Brand
Cordis Corporation
Lot Codes / Batch Numbers
Lot numbers R0305581, R0305159, R0305284, R0305286, R0305155 and R0305104.
Products Sold
Lot numbers R0305581, R0305159, R0305284, R0305286, R0305155 and R0305104.
Cordis Corporation is recalling Product is a Powerflex P3 Dialation Catheter. Product is labeled in part: ''***POWERFLEX P3***Cordis due to During competitive product testing, wire movement difficulties were observed in Powerflex P3 units. Due to the possibility of user inconvenience, Cord. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Recalled by letter and Cordis Sales Representatives interfacing directly with US consignees.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN
Page updated: Jan 10, 2026