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U.S. Department of Health and Human Services

Class 2 Device Recall Corkscrew Catheter

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 Class 2 Device Recall Corkscrew Cathetersee related information
Date Initiated by FirmJuly 06, 2017
Create DateAugust 26, 2017
Recall Status1 Terminated 3 on October 17, 2018
Recall NumberZ-3077-2017
Recall Event ID 77802
510(K)NumberK901625 
Product Classification Catheter, embolectomy - Product Code DXE
ProductFogarty Adherent Clot Catheter Model Numbers 1408010 and 140806 Product Usage: The Fogarty adherent clot catheters are designed to effectively remove clot material in the peripheral vasculature. The catheters are indicated for the removal of emboli and thrombi from native arteries or synthetic grafts. The device are designed to facilitate clots too resistant to be removed by an elastomeric balloon. The device features a spiral-shaped, latex-covered stainless steel cable that assumes a corkscrew shape when retracted, greatly expanding the surface areas to entrap fibrous material. The device is 80 cm in length and is available in 4F-6F diameters.
Code Information Lots 60439817 and 60439818
Recalling Firm/
Manufacturer		 Edwards Lifesciences, LLC
1 Edwards Way
Irvine CA 92614-5688
For Additional Information ContactEdwards Customer Service
800-424-3278
Manufacturer Reason
for Recall		The diameter of the Fogarty Catheter balloon, measures 6mm instead of 10mm.
FDA Determined
Cause 2		Packaging
ActionRecall notification letters were sent to affected customers on 7/6/2017. The recall notice included a response form and instructed consignee to return any unused devices..
Quantity in Commerce200 units
DistributionWorldwide Distribution - US Nationwide GB, NL, DE, IT, FR, BE, ES, NO, CZ, BG, SE, AT, CH, PL, RU, FI
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 = DXE
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