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U.S. Department of Health and Human Services

Class 1 Device Recall WORKER Guidewire, Amplatz, Straight

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 Class 1 Device Recall WORKER Guidewire, Amplatz, Straightsee related information
Date Initiated by FirmDecember 04, 2019
Date PostedMay 07, 2020
Recall Status1 Terminated 3 on April 01, 2024
Recall NumberZ-1791-2020
Recall Event ID 85398
510(K)NumberK160785 
Product Classification Wire, guide, catheter - Product Code DQX
Product0.035"(.89mm)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI: 114135080/(01)208863333008067. RxOnly STERILE EO
Code Information Guidewire Model 114135080; LOT numbers: 11235895, 11234476, 11237014, and 11240602. 
FEI Number 1625425
Recalling Firm/
Manufacturer		 Argon Medical Devices, Inc
1445 Flat Creek Rd
Athens TX 75751-5002
For Additional Information ContactMr. Scott Bishop
469-430-0546
Manufacturer Reason
for Recall		The stiffness of the soft end of the guidewire caused tissue perforation.
FDA Determined
Cause 2		Employee error
ActionOn 12/04/2019, the firm sent Medical Device Recall letter by email to their customer/ distributors. Customers are instructed to inspect and quarantine and return any affected product remaining at their facility utilizing the instruction on the Recall Response Form. Customers are instructed to complete the response acknowledgement form included with the letter and return by fax, mail or email as soon as possible. Customers were also instructed to pass the notice on to all those who need to be aware within their organization or to any organization to which the potentially affected devices have been transferred.
Quantity in Commerce1690 units
DistributionNo US consignees. OUS - Sweden, Norway, Denmark, Greece, Slovenia, Turkey, Hong Kong, England
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DQX
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