Recall Z-0557-04 ยท FGO Dislodger, Stone, Flexible
Scion Cardio-Vascular, Inc.
The device is SCIPRO Flexible Stone Dislodger and Retrieval Set, Catalog # SP3000146-ST used for removal of calculi, fragments of medical devices and other foreign objects uring urological or gatroenterological procedures. The device has the manufacturer listed on the label which is Scion Cardio-Vascular, Inc., 14256 SW 119 Avenue, Miami, FL 33186.
| Date | Feb 27, 2004 (initiated Jun 30, 2003) |
| Status | Terminated |
| Reason | The firm received field complaints that it was difficult to open the stone retrieval basket during use. |
| Root cause | Other |
| Action | The firm mailed a recall letter to there consignees on June 30, 2003 requesting return of any unused devices. The firm has received 100% response and accounted for all recalled devices. |
| Quantity | 41 |
| Distribution | The software systems were installed at 2 medical centers in Illinois and Alabama. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001563 | SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET Scion Cardiovascular, Inc., Nov 22, 2000 |