FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0557-04
- 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.
- Status
- Terminated
- Initiated
- 2003-06-30
- Posted
- 2004-02-27
- Terminated
- 2004-05-07
- 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.
- Lot, serial or model codes
- Lot Number OML30522-01
- 510(k) numbers
- ["K001563"]
- PMA numbers
- not on file
- Product code
- FGO
- Firm FEI
- 1000113395
- Firm city
- Miami
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28