Z-1477-2020Class II

Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S

Name: Z-1477-2020 Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S
Creator: Cordis Corporation
Published: 2020-01-08
License: https://open.fda.gov/license/

Cordis US Corp. / initiated 2020-01-08 / Terminated

FDA source

Cordis Corporation began a recall of Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S on 2020-01-08. FDA classified it as Class II and gives the reason as "Cordis is recalling one (1) lot of POWERFLEX P3 PTA Dilatation Catheter due to the potential for body/shaft voids in the proximal seal area". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1477-2020
Classification: Class II
Status: Terminated
Initiated: 2020-01-08
Posted: 2020-02-28
Terminated: 2023-01-13
Recalling firm: Cordis US Corp.
Product: Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S
Product code: LIT Catheter, Angioplasty, Peripheral, Transluminal
Reason for recall: Cordis is recalling one (1) lot of POWERFLEX P3 PTA Dilatation Catheter due to the potential for body/shaft voids in the proximal seal area.
FDA root cause: Pending
Action: The firm initiated the recall by letter on 01/08/2020. The letter explained the issue and the hazard, and requested the consignee check their inventory for the product, isolate any affected units and return the acknowledgement form. The firm is seeking the return of the affected units. The firm directed the consignee to share the notice with any entity to whom the product was further distributed. Questions regarding the recall should be sent to: [email protected].
Quantity in commerce: 89 units
Distribution: US and UK
Product codes and lots: Lot 82155955, Use by date 2021-06-30

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1477-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1477-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-18	2020-03-12

Product code LIT

K032737Class IICordis Powerflex Extreme Pta Balloon Catheter, Cordis Powerflex Plus Pta Balloon Catheter, Cordis Powerflex P3 PtaCordis Europa, N.V. / cleared 2003-10-02

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)