Z-0839-2007

Silver Speed Hydrophilic Guidewire, for placement of vascular catheters. Model # 103-0601-200

Name: Z-0839-2007 Silver Speed Hydrophilic Guidewire, for placement of vascular catheters. Model # 103-0601-200
Creator: EV3 Neurovascular
Published: 2007-04-05
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2007-04-05 / Terminated

FDA source

EV3 Neurovascular began a recall of Silver Speed Hydrophilic Guidewire, for placement of vascular catheters. Model # 103-0601-200 on 2007-04-05. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0839-2007
Status: Terminated
Initiated: 2007-04-05
Posted: 2007-06-07
Terminated: 2012-08-23
Recalling firm: Medtronic, Inc.
Product: Silver Speed Hydrophilic Guidewire, for placement of vascular catheters. Model # 103-0601-200.
Product code: MKI
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 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 in commerce: 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
Product codes and lots: 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;

Product code MKI

K982543Class IISilverstreak Hydrophilic GuidewireMicro Therapeutics, Inc. / cleared 1998-12-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)