TrailBlazer Support Catheter, ev3 inc, 4600 Nathan Lane North, Plymouth, MN 55442-2920, Rx Only, Sterile EO. US Model Nu
FDA device recall Z-0497-2010 · posted 2009-12-23 · Terminated
Recall details
- Recalling firm
- Ev3, Inc.
- Reason for recall
- Catheter may crack near the radiopaque marker band at the distal end of the device during use. Cracking of the catheter shaft in this location can result in material separation, and potential embolization.
- Action taken
- Consignees were sent a Medical Device Recall letter, dated 11/6/09. The letter was addressed to Risk Manger or Cath Lab Manage. The letter provided the Issue Summary, identified the Affected Product, and stated the Required Action, which asked consignees to locate and remove the affected product. Questions should be directed to ev3 Customer Service at 800-716-6700.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- DQY
- Quantity affected
- 70
- Distribution
- Nationwide Distribution -- USA, including states of CA, FL, GA, IL, IN, IA, KS, KY, MI, MT, NJ, PA, SD, TN, TX, and WI.
- Date initiated
- 2009-11-06
- Date posted
- 2009-12-23
- Date terminated
- 2011-01-05
- Location
- Plymouth, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRAILBLAZER SUPPORT CATHETER (K092299) | Ev3, Inc. | 2009-08-07 |