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U.S. Department of Health and Human Services

Class 2 Device Recall PTFE Coated 3 cm Flexible Tip Guidewire

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  Class 2 Device Recall PTFE Coated 3 cm Flexible Tip Guidewire see related information
Date Initiated by Firm April 15, 2011
Date Posted May 26, 2011
Recall Status1 Terminated 3 on August 23, 2012
Recall Number Z-2383-2011
Recall Event ID 58650
Product Classification Accessories, catheter, g-u - Product Code KNY
Product Gyrus ACMI, REF 25 BX, PTFE Coated 3 cm Flexible Tip Guidewire, .035" x 150 cm, Sterile EO, Rx Only, Gyrus ACMI, Inc. 136 Turnpike Road,Southborough, MA 01772-2104 USA

Ureteral guidewires are used to establish access in the urinary system for the passage of urological devices. An introducer is first used to establish entry to various portions of the urinary tract (urethra, bladder, ureter), then a guidewire is threaded through the introducer. Following placement of the guidewire, various urological devices can be introduced into the targeted portion of the urinary tract for various therapeutic and diagnostic procedures.
Code Information Lot Number 252410KC 
Recalling Firm/
Gyrus Acmi, Incorporated
136 Turnpike Road
Southborough MA 01772-2118
For Additional Information Contact
Manufacturer Reason
for Recall
Gyrus ACMI, Inc. wants to bring a recall issue to their customers attention concerning one lot of their 25BX-PTFE Coated 3 cm Flexible Tip Guidewire. As a result of a manufacturing error in the production this lot of guidewires, some units of product were loaded in the dispenser backwards. In such cases, the stiff end of the guidewire would be dispensed from the product first and, if undetected, could be inserted into the patient. Depending on the specific clinical circumstances of the patient, this could potentially cause perforation of the ureter and surrounding anatomy. Therefore Gyrus ACMI has chosen, out of an abundance of caution, to conduct a voluntary recall of this lot of product.
FDA Determined
Cause 2
Process control
Action The firm, Olympus ACMI, sent an "Urgent: Medical Device Recall" letter dated April 15, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: 1) Inspect their stock to confirm if any of the affected lot of products remains in their possession 2)Immediately cease any further use of the affected product, remove, quarantine and return it. 3) Call their Gyrus ACMI customer service representative at 1-888-542-7266 to obtain a Returned Goods Authorization 4) Return the product to: Attn: PTFE Guidewire Recall RGA#_________Gyrus ACMI LP, 6845 Wedgwood Court, Maple Grove, MN 55311 5) Complete and return the RECALL REPLY FORM via fax, even if they are returning no product, to: Regulator Affairs (508) 804-2624. The letter states that the customer will receive repeat mailings until they have faxed in the form. Additionally, If they have further distributed the product they are requested to identify and notify their customers at once. If you have any questions, please do not hesitate to contact customer service at 1-888-524-7266.
Quantity in Commerce 145
Distribution Nationwide distribution: USA including states of: CA, GA, HI, IN, KY, MT, NY, NC, PA, TX, UT, and WA.
Total Product Life Cycle TPLC 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.