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U.S. Department of Health and Human Services

Class 2 Device Recall The Coaxial MicroIntroducer i

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  Class 2 Device Recall The Coaxial MicroIntroducer i see related information
Date Initiated by Firm September 08, 2016
Date Posted November 18, 2016
Recall Status1 Terminated 3 on September 08, 2017
Recall Number Z-0623-2017
Recall Event ID 75145
510(K)Number K071574  
Product Classification Introducer, catheter - Product Code DYB
Product Greatbatch Stiffer Coaxial Micro-Introducer. Model #/ Name: 10904-001 Stiffer Coaxial Micro-Introducer 4FR; 10904-002 Stiffer Coaxial Micro-Introducer 5FR.

The radiopaque Stiffer Coaxial Micro-Introducer (Figure 1) consists of a dilator and sheath, available in 4FR and 5FR. The inner dilator includes a stainless steel stiffening hypotube. The Coaxial Micro-Introducer is indicated for percutaneous introduction of up to a 0.038 in. guidewire or catheter into the vascular system through an initial puncture of a 21G introducer. The device is sold to customers
in a bulk non-sterile configuration.
Code Information GBP3176925, GBP3176927, VN3470927, VN3470929, VN3486000, VN3485998, VN3495047, GBP3421664, VN3433259, VN3451654, VN3487654, VN3491069, VN3470925, VN3451646.
Recalling Firm/
Greatbatch Medical
2300 Berkshire Ln N
Plymouth MN 55441-4575
For Additional Information Contact local Greatbatch Medical representative
Manufacturer Reason
for Recall
Greatbatch Medical has identified an issue with the Stiffer Coaxial Micro-Introducer 4FR and 5FR after a field complaint reported that the rotating luer detached from the dilator hub during use.
FDA Determined
Cause 2
Process design
Action Greatbatch sent a "Urgent Medical Device Recall" letter dated September 7, 2016 to all affected customers .The letter described the product, "Reason for Field Correction Action", "Risk to Health" , "Replacement Devices", & "Instructions to Customers" . Advised customers to quarantine the product and contact end users and share the recall information with them. Requested consignees to complete & return the Field Recall Response Form. For questions contact your local Greatbatch Medical representative, contact us at 1-763-951-8235, or e-mail us at FieldActionCenter@Greatbatch.com.
Quantity in Commerce 23,075
Distribution US: NY, TX.
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.
510(K) Database 510(K)s with Product Code = DYB and Original Applicant = ENPATH MEDICAL, INC.