Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG387312, .035/300cm, stiff/angled/standard, sold as a single hydrophilic guidewire in both sterile and bulk non-sterile packaging configurations. Argon Medical Devices, Inc. Athens, TX 75751
FDA Recall Z-0888-2008 · Posted 2008-01-31
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Recalling FirmArgon Medical Devices, Inc
Recall StatusTerminated
Product CodeDQX
Date Initiated2007-11-19
Date Terminated2008-06-05
Product Quantity375
Reason for Recall
Degradation -- Hydrophilic guidewires may exhibit degradation of blue Pebax cladding causing particulate to dislodge potentially resulting in embolism.
Firm Action
Argon Medical sent an Urgent Product Recall letter to consignees on 11/15/2007. They requested that users immediately quarantine and return any product remaining at their facility, utilizing instruction on response card. Distributors were directed to issue the recall to their customers and return all retrieved product to Argon.
Root Cause
Process design
Distribution Pattern
Worldwide Distribution -- USA including states of FL, KS, NV, IL, CA, NY, CO, VA, MD, NC, UT, GA, MI, NJ, TN, MA, and CT, and countries of The Netherlands, Germany, and Turkey.
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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