Device product

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

Z-1477-2020

January 08, 2020

Class II

Product summary

Firm: Cordis Corporation
Event: Event 84680
Status: Terminated
Classification: Class II
Quantity: 89 units
Official record key: device-enforcement:Z-1477-2020

Official wording

Reason: 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.

Code information: Lot 82155955, Use by date 2021-06-30

Distribution pattern: US and UK

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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.