Silver Speed Hydrophilic Guidewire, for placement of vascular catheters. Model # 103-0601-200. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Silver Speed Hydrophilic Guidewire, for placement of vascular catheters. Model # 103-0601-200.
Lot Codes / Batch Numbers
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
Products Sold
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;
A medical device manufacturer is recalling Silver Speed Hydrophilic Guidewire, for placement of vascular catheters. Model # 103-0601-200. due to Two customer complaints were received from physicians in Japan indicating the hydrophilic coating was observed flaking from the guidewire while immers. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
A 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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026