FDA Medical Device Recalls (openFDA)
Scion Cardio-Vascular, Inc.: SCIPRO Flexible Stone Dislodger and Retrieval Set Catalog # SP3000146ST
- Recall number
- Z-0554-04
- Recalling firm
- Scion Cardio-Vascular, Inc.
- Product
- SCIPRO Flexible Stone Dislodger and Retrieval Set Catalog # SP3000146ST
- Status
- Terminated
- Initiated
- 2003-05-23
- Posted
- 2004-02-27
- Terminated
- 2004-05-07
- Reason
- Possible difficulty for the user in opening the stone retrieval basket.
- 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
- 28
- Distribution
- Product was distributed 12 hospitals and clinics in NJ, RI, NY, PA, VA, KY, TX, OH, TX AND FL.
- Lot, serial or model codes
- Lot # OML30403-01
- 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