Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Length 49 cm, Coronary Sinus - Multi
FDA device recall Z-0793-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Guidant Corp-Cpi Division
- Reason for recall
- The terminal hub component in a some of the catheters has an unintended abrupt transition between the entry port and the catheter lumen which can result in difficulty introducing or removing delivery system components during lead placement.
- Action taken
- Starting on March 11, 2003, the firm''s representatives visited consignees, to whom the recalled catheters had been consigned, and retrieved the catheters.
- Root cause
- Other
- Status
- Terminated
- Product code
- DQR
- Quantity affected
- 61 catheters
- Distribution
- Nationwide in the United States.
- Date initiated
- 2004-03-11
- Date posted
- 2004-07-20
- Date terminated
- 2005-10-31
- Location
- Saint Paul, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RAPIDO GUIDING CATHETER, 6F MODEL# 6776; RAPIDO GUIDING CATHETER, 8F MODEL# 6775, 6777, 6778, 6779, 6780, 6781, 6782, (K021455) | Guidant Corp. | 2002-08-02 |
| EASYTRAK GUIDING CATHETER (K021284) | Guidant Corp. | 2002-05-02 |