Z-0557-04

The device is SCIPRO Flexible Stone Dislodger and Retrieval Set, Catalog # SP3000146-ST used for removal of...

Name: Z-0557-04 The device is SCIPRO Flexible Stone Dislodger and Retrieval Set, Catalog # SP3000146-ST used for removal of...
Creator: Scion Cardio-Vascular, Inc.
Published: 2003-06-30
License: https://open.fda.gov/license/

Scion Cardio-Vascular, Inc. / initiated 2003-06-30 / Terminated

FDA source

Scion Cardio-Vascular, Inc. began a recall of The device is SCIPRO Flexible Stone Dislodger and Retrieval Set, Catalog # SP3000146-ST used for removal of calculi, fragments of medical devices and other... on 2003-06-30. The reason FDA records is "The firm received field complaints that it was difficult to open the stone retrieval basket during use". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0557-04
Status: Terminated
Initiated: 2003-06-30
Posted: 2004-02-27
Terminated: 2004-05-07
Recalling firm: Scion Cardio-Vascular, Inc.
Product: 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.
Product code: FGO Dislodger, Stone, Flexible
Reason for recall: The firm received field complaints that it was difficult to open the stone retrieval basket during use.
FDA 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 in commerce: 41
Distribution: The software systems were installed at 2 medical centers in Illinois and Alabama.
Product codes and lots: Lot Number OML30522-01

Product code FGO

K001563Class IIScipro(tm) Flexible Stone Dislodger and Retrieval SetScion Cardiovascular, Inc. / cleared 2000-11-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)