Recall Z-0804-04 ยท DQR Cannula, Catheter
Guidant Corp-Cpi Division
Guidant Rapido 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Lenght 54 cm, Coronary Sinus - Extended Hook Right Tip Shape, CS-EH R, REF 7592
| 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 | 43 catheters |
| Distribution | Nationwide in the United States. |
| FDA record | Open on fda.gov |