AngioScore Inc. AngioSculpt PTCA Scoring Balloon Catheter, Catalog (REF) Number: 2027-2510, size 2.5mm x 10 mm, AngioScore, Inc., Fremont, CA. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
AngioSculpt PTCA Scoring Balloon Catheter, Catalog (REF) Number: 2027-2510, size 2.5mm x 10 mm, AngioScore, Inc., Fremont, CA.
Brand
AngioScore Inc.
Lot Codes / Batch Numbers
Lot Number: F07090015
Products Sold
Lot Number: F07090015
AngioScore Inc. is recalling AngioSculpt PTCA Scoring Balloon Catheter, Catalog (REF) Number: 2027-2510, size 2.5mm x 10 mm, Angi due to Mis-labeling: Product labeling on product pouch indicates wrong size, the correct size is on the product carton. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Mis-labeling: Product labeling on product pouch indicates wrong size, the correct size is on the product carton
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026