FDA Medical Device Recalls (openFDA)
EV3 Neurovascular: Silver Speed Hydrophilic Guidewire, for placement of vascular catheters. Model # 103-0601-200.
- Recall number
- Z-0839-2007
- Recalling firm
- EV3 Neurovascular
- Product
- Silver Speed Hydrophilic Guidewire, for placement of vascular catheters. Model # 103-0601-200.
- Status
- Terminated
- Initiated
- 2007-04-05
- Posted
- 2007-06-07
- Terminated
- 2012-08-23
- Reason
- 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.
- Root cause
- Other
- Action
- 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.
- Quantity
- 2120
- Distribution
- Worldwide, 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
- Lot, serial or model codes
- 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;
- 510(k) numbers
- ["K982543"]
- PMA numbers
- not on file
- Product code
- MKI
- Firm FEI
- 3004904811
- Firm city
- Irvine
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28