Z-1556-05

Product is a Powerflex P3 Dialation Catheter. Product is labeled in part: ''POWERFLEX P3Cordis***a...

Name: Z-1556-05 Product is a Powerflex P3 Dialation Catheter. Product is labeled in part: ''***POWERFLEX P3***Cordis***a...
Creator: Cordis Corporation
Published: 2005-05-11
License: https://open.fda.gov/license/

Cordis US Corp. / initiated 2005-05-11 / Terminated

FDA source

Cordis Corporation began a recall of Product is a Powerflex P3 Dialation Catheter. Product is labeled in part: ''***POWERFLEX P3***Cordis***a Johnson and Johnson company***ENDOVASCULAR***STERILE... on 2005-05-11. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1556-05
Status: Terminated
Initiated: 2005-05-11
Posted: 2005-09-21
Terminated: 2008-11-20
Recalling firm: Cordis US Corp.
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***''
Product code: LIT Catheter, Angioplasty, Peripheral, Transluminal
Reason for recall: 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.
FDA root cause: Other
Action: Recalled by letter and Cordis Sales Representatives interfacing directly with US consignees.
Quantity in commerce: 48 units
Distribution: Distributed to 35 consignees throughout the US and other consignees in 11 countries worldwide.
Product codes and lots: Lot numbers R0305581, R0305159, R0305284, R0305286, R0305155 and R0305104.

Product code LIT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)