Cordis Aquatrack Hydrophilic Nitinol Guidewire, for use in angiographic procedures, REF C3526-SSA, Guidewire Diameter .035" Tip Length Flexible 3 cm, Sterile. Contents 5 Hydrophilic guidewires and torquing devices.
FDA Recall Z-0623-2010 · Posted 2010-01-13
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Recalling FirmCordis Corporation
Recall StatusTerminated
Product CodeDQX
Date Initiated2009-08-25
Date Terminated2010-08-11
Product Quantity145 units
Reason for Recall
Some of the guidewires in these two lots have a straight tip (incorrect) rather than an angled tip (correct configuration for that catalog number).
Firm Action
Recall for Lot 80000521 was initiated on August 25, 2009 with Cordis Medical Device Recall letters being mailed for delivery on August 25, 2009. Response form was also provided to obtain product disposition.
Recall for Lot 80000584 was initiated on October 19, 2009 with Cordis Medical Device Recall letters being mailed for delivery on October 20, 2009. Response form was also provided to obtain product disposition.
Root Cause
Process control
Distribution Pattern
Nationwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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