Silver Speed Hydrophilic Guidewire, for placement of vascular catheters. Model # 103-0601-200.
FDA device recall Z-0839-2007 · posted 2007-06-07 · Terminated
Recall details
- Recalling firm
- EV3 Neurovascular
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- MKI
- Quantity affected
- 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, Venez
- Date initiated
- 2007-04-05
- Date posted
- 2007-06-07
- Date terminated
- 2012-08-23
- Location
- Irvine, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SILVERSTREAK HYDROPHILIC GUIDEWIRE (K982543) | Micro Therapeutics, Inc. | 1998-12-11 |