Z-0554-04

SCIPRO Flexible Stone Dislodger and Retrieval Set Catalog # SP3000146ST

Name: Z-0554-04 SCIPRO Flexible Stone Dislodger and Retrieval Set Catalog # SP3000146ST
Creator: Scion Cardio-Vascular, Inc.
Published: 2003-05-23
License: https://open.fda.gov/license/

Scion Cardio-Vascular, Inc. / initiated 2003-05-23 / Terminated

FDA source

Scion Cardio-Vascular, Inc. began a recall of SCIPRO Flexible Stone Dislodger and Retrieval Set Catalog # SP3000146ST on 2003-05-23. The reason FDA records is "Possible difficulty for the user in opening the stone retrieval basket". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0554-04
Status: Terminated
Initiated: 2003-05-23
Posted: 2004-02-27
Terminated: 2004-05-07
Recalling firm: Scion Cardio-Vascular, Inc.
Product: SCIPRO Flexible Stone Dislodger and Retrieval Set Catalog # SP3000146ST
Product code: FGO Dislodger, Stone, Flexible
Reason for recall: Possible difficulty for the user in opening the stone retrieval basket.
FDA root cause: Other
Action: The firm mailed a recall letter on May 23, 2003 with a pre-paid FedEx shipment label to the consignees requesting that they return the indicated product and lot number. The firm recieved a response from each consignee and accounted for all shipped product by 6/24/2003.
Quantity in commerce: 28
Distribution: Product was distributed 12 hospitals and clinics in NJ, RI, NY, PA, VA, KY, TX, OH, TX AND FL.
Product codes and lots: Lot # OML30403-01

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)