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Terminated

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

FDA Recall Z-1477-2020 · Posted 2020-02-28

Recalling FirmCordis Corporation
Recall StatusTerminated
Product CodeLIT
Date Initiated2020-01-08
Date Terminated2023-01-13
Product Quantity89 units

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.

Firm 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].

Root Cause

Pending

Distribution Pattern

US and UK

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K032737CORDIS POWERFLEX EXTREME PTA BALLOON CATHETER, CORDIS POWERFLEX PLUS PTA BALLOON CATHETER, CORDIS POWERFLEX P3 PTACordis Europa, N.V. · 2003-10-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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