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U.S. Department of Health and Human Services

Class 2 Device Recall Silver Speed Hydrophilic Guidewire

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 Class 2 Device Recall Silver Speed Hydrophilic Guidewiresee related information
Date Initiated by FirmApril 05, 2007
Date PostedJune 07, 2007
Recall Status1 Terminated 3 on August 23, 2012
Recall NumberZ-0839-2007
Recall Event ID 37821
510(K)NumberK982543 
Product Classification vascular catheter guidewire - Product Code MKI
ProductSilver Speed Hydrophilic Guidewire, for placement of vascular catheters. Model # 103-0601-200.
Code Information US: Lot # : 2295725; 2382836; 2355074; 2390635; 2348116; 2355074; 2374619; 2216295; 2257803;2390635; 2342166; ;2390635;2348116; 2310664; 2382836; 2257803; 2216295; 2310664; 2390635; 2247199; 2247200; 2221847; 2247200; 2295725; 2310664; 2221845; 2310664; 2216296; 2257803; 2342166;   European Union & Rest-Of-World Lot #:  2374619 ; 2209708;2216295; 2247200; 2310664; 2348116; 2221845 ; 2355074; 2247200; 2310664; 2216295; 2166877; 2247199; 2209708; 2367901; 2370509; 2374619; 2216295; 2163496; 2174470; 2295725; 2370509; 2376907; 2209708; 2295725; 2310664; 2221845; 2247200; 2216291; 2390635; 2360938; 2370509; 2376907; 2310664; 2355074; 2163496; 2276405; 2370508; 2221847; 2257803; 2390635; 2257803; 2370509; 2200727;
FEI Number 3004904811
Recalling Firm/
Manufacturer		 EV3 Neurovascular
9775 Toledo Way
Irvine CA 92618-2054
For Additional Information ContactRobert Salvucci
949-837-3700
Manufacturer Reason
for Recall		Two customer complaints were received from physicians in Japan indicating the hydrophilic coating was observed flaking from the guidewire while immersed in hydrating media following use during aneurysm embolization procedures.
FDA Determined
Cause 2		Other
ActionA recall plan was developed for 100% recovery of guidewires within affected lot numbers. The plan includes notification to U.S., European, and Rest-of-World customers and distributors. A recall notification letter was prepared 04/05/2007 which summarizes the coating problem and potential risks, identifies the affected lot numbers and quantities shipped to the customer, and provides instructions for return of unused guidewires.
Quantity in Commerce2120
DistributionWorldwide, including USA, Italy, United Kingdom, Switzerland, Germany, Belgium, South Africa, Canada, Slovenia, China, Austria, France, Spain, Jordan, Mexico, Portugal, Colombia, Greece, Brazil, Venezula, Ireland, Australia, Malaysia, Saudi Arabia, South Korea, Lithuania, Netherlands, Hungary, and United Arab Emirates
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 = MKI
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