Reported Dec 4, 2024 · Ongoing
AMS Artificial Urinary Sphincter Control Pump
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?
- AMS Artificial Urinary Sphincter Control Pump
- Lot codes and dates
- UPN Number72400098
- GTIN Number00878953000688
- Lot Number32487464
- Serial Numbers
1100366307110036631611003663091100366317110036631011003663191100366311110036632011003663121100366321110036631311003663231100366314110036632411003663151100366325
- Expiration Date09/24/2028
- Amount recalled
- 16 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098)
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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