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Terminated

Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X

FDA Recall Z-2235-2021 · Posted None

Recalling FirmCordis Corporation
Recall StatusTerminated
Product CodeLIT
Date Initiated2021-07-19
Date Terminated2023-02-16
Product Quantity8 units

Reason for Recall

The balloon protective sheath may potentially be contaminated with a foreign material left over from the manufacturing process. The contaminant may transfer over from the sheath to the balloon.

Firm Action

The firm initiated the recall by letter on 07/19/2021. The letter explained the issue and requested the return of the devices.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide distribution - US Nationwide distribution in the states of CA, OH, and the countries of Switzerland, Portugal, and Poland.

Official Source

View FDA Recall →

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

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