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Completed

PRECISE PRO RX CAROTID STENT implant system, Product Codes: PC0520RXC, PC0530RXC, PC0540RXC, PC0620RXC, PC0630RXC, PC0640RXC, PC0720RXC, PC0730RXC, PC0740RXC, PC0820RXC, PC0830RXC, PC0840RXC, PC0920RXC, PC0930RXC, PC0940RXC, PC1030RXC, PC1040RXC

FDA Recall Z-1257-2021 · Posted None

Recalling FirmCordis Corporation
Recall StatusCompleted
Product CodeNIM
Date Initiated2021-02-11
Product Quantity18218 units

Reason for Recall

Distal tip may become separated from the lumen wire in specific lots.

Firm Action

The firm initiated the recall by letter on 02/11/2021. The letter explained the reason for recall and potential impact to the patient, along with the request to further disseminate the notices and return of the recalled units.

Root Cause

Process control

Distribution Pattern

US (except MT and NM) and Taiwan

Official Source

View FDA Recall →

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

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