Z-0591-2008

AngioSculpt PTCA Scoring Balloon Catheter, Catalog (REF) Number: 2027-2510, size 2.5mm x 10 mm, AngioScore...

Name: Z-0591-2008 AngioSculpt PTCA Scoring Balloon Catheter, Catalog (REF) Number: 2027-2510, size 2.5mm x 10 mm, AngioScore...
Creator: AngioScore Inc.
Published: 2007-11-13
License: https://open.fda.gov/license/

Spectranetics Corp. / initiated 2007-11-13 / Terminated / root cause: manufacturing process

FDA source

AngioScore Inc. began a recall of AngioSculpt PTCA Scoring Balloon Catheter, Catalog (REF) Number: 2027-2510, size 2.5mm x 10 mm, AngioScore, Inc., Fremont, CA on 2007-11-13. The reason FDA records is "Mis-labeling: Product labeling on product pouch indicates wrong size, the correct size is on the product carton". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0591-2008
Status: Terminated
Initiated: 2007-11-13
Posted: 2008-01-23
Terminated: 2008-03-25
Recalling firm: Spectranetics Corp.
Product: AngioSculpt PTCA Scoring Balloon Catheter, Catalog (REF) Number: 2027-2510, size 2.5mm x 10 mm, AngioScore, Inc., Fremont, CA.
Product code: NWX Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring
Reason for recall: Mis-labeling: Product labeling on product pouch indicates wrong size, the correct size is on the product carton
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: Lot Number: F07090015

Product code NWX

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)