Reported Dec 4, 2024 · Ongoing
AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O
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 Pressure Regulating Balloon 61-70 cm H2O
- Lot codes and dates
- UPN Number72400024
- GTIN Number00878953000626
- Lot Numbers
325007393250082132500820
- Serial Numbers
11003660881100366115110036608911003661161100366090110036611711003660911100366118110036609211003661191100366093110036612011003660941100366121110036609511003661221100366096110036612311003660971100366144110036609811003661451100366099110036614611003661001100366147110036610111003661481100366102110036614911003661031100366150110036610411003661511100366105110036615211003661061100366153110036610711003661541100366108110036615511003661091100366156110036611011003661571100366111110036615811003661121100366159110036611311003661601100366114
- Expiration Date09/23/2028
- Amount recalled
- 52 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.
Want the full recall guide?
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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