Reported Sep 11, 2019 · Terminated

AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: 72400161

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 · 300 Boston Scientific Way · Marlborough, MA · 01752-1291

Is this the product you have?

  • AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5
  • cm Part Number72400161
Lot codes and dates
  • Lot Number23973023
Amount recalled
1 unit

Where it was sold

Why it was recalled

Mislabled: AMS 800 occlusive cuff labeled as 4.5 cm was a length of 4.0 cm and therefore..

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 Apr 23, 2020 · Data as of Sep 19, 6:22 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.