Recall Z-0801-04 ยท DQR Cannula, Catheter
Guidant Corp-Cpi Division
Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Length 54 cm, Coronary Sinus - Multi-Purpose Long Tip Shape, CS-MPL, REF 7507
| Date | Jul 20, 2004 (initiated Mar 11, 2004) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | Starting on March 11, 2003, the firm''s representatives visited consignees, to whom the recalled catheters had been consigned, and retrieved the catheters. |
| Quantity | 20 catheters |
| Distribution | Nationwide in the United States. |
| FDA record | Open on fda.gov |