Reported Jul 17, 2013 · Terminated

NephroMax high Pressure Nephrostomy Balloon Catheter. Material Number/Catalog Number: M0062101400/210-140,…

Boston Scientific Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Boston Scientific Corporation · 100 Boston Scientific Way · Marlborough, MA · 01752-1234

Is this the product you have?

  • NephroMax high Pressure Nephrostomy Balloon Catheter
  • Material Number/Catalog NumberM0062101400/210-140, M062101440/210144 Dilation of the nephrostomy tract
Lot codes and dates
  • Lot Number
    • 15875861
    • 15875860
    • 15875299
    • 15872797
    • 15872799
    • 15872798
Amount recalled
27

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

Why it was recalled

Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 23, 2014 · Data as of Sep 19, 4:48 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.