FDA Medical Device Recalls (openFDA)
AngioScore Inc.: AngioSculpt PTCA Scoring Balloon Catheter, Catalog (REF) Number: 2027-2510, size 2.5mm x 10 mm, AngioScore, Inc., Fremont, CA.
- Recall number
- Z-0591-2008
- Recalling firm
- AngioScore Inc.
- Product
- AngioSculpt PTCA Scoring Balloon Catheter, Catalog (REF) Number: 2027-2510, size 2.5mm x 10 mm, AngioScore, Inc., Fremont, CA.
- Status
- Terminated
- Initiated
- 2007-11-13
- Posted
- 2008-01-23
- Terminated
- 2008-03-25
- Reason
- Mis-labeling: Product labeling on product pouch indicates wrong size, the correct size is on the product carton
- Root cause
- Process control
- Action
- The firm initiated a field correction and issued Medical Device Field correction letters to its consignees on 11/09/2007, instructing consignees to review their inventory and return any mislabeled product or contact the firm.
- Quantity
- 40 units
- Distribution
- Nationwide-to 30 medical facilities in NC, SC, OH, IL, NY, PA, NJ, PA, LA, KS, FL, WI, MI, WA, and CA.
- Lot, serial or model codes
- Lot Number: F07090015
- 510(k) numbers
- not on file
- PMA numbers
- ["P050018"]
- Product code
- NWX
- Firm FEI
- 3005462046
- Firm city
- Fremont
- Firm state
- CA
- 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