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AngioSculpt PTCA Scoring Balloon Catheter, Catalog (REF)… recallZ-0591-2008 · AngioScore Inc. · initiated Nov 13, 2007

Terminated All recalls posted in January 2008

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from AngioScore Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Mis-labeling: Product labeling on product pouch indicates wrong size, the correct size is on the product carton

FDA root cause category: Process control

What the company is doing

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.

Recall details

Recall number
Z-0591-2008
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Nov 13, 2007
Posted by the FDA
Jan 23, 2008
Recalling firm
AngioScore Inc.
Quantity
40 units
Product code
NWX
FDA submissions
P050018
Distribution
Nationwide-to 30 medical facilities in NC, SC, OH, IL, NY, PA, NJ, PA, LA, KS, FL, WI, MI, WA, and CA.

Product description

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

Code information (models, lots, serial numbers)

Lot Number: F07090015

Other devices under the same FDA submission

21 devices cleared under P050018 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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