Argon Medical Devices, Inc Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG087312, .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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG087312, .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
Brand
Argon Medical Devices, Inc
Lot Codes / Batch Numbers
Lot Numbers: 99513867, 99508829, and 99508830
Products Sold
Lot Numbers: 99513867, 99508829, and 99508830
Argon Medical Devices, Inc is recalling Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG087312, . due to Degradation -- Hydrophilic guidewires may exhibit degradation of blue Pebax cladding causing particulate to dislodge potentially resulting in embolism. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Degradation -- Hydrophilic guidewires may exhibit degradation of blue Pebax cladding causing particulate to dislodge potentially resulting in embolism.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, CO, CT, FL, GA, IL, KS, MD, MA, MI, NV, NJ, NY, NC, TN, UT, VA
Page updated: Jan 10, 2026