AMS Artificial Urinary Sphincter Balloon Mislabeled With Wrong Component
Boston Scientific recalls 52 mislabeled AMS Artificial Urinary Sphincter balloons that may contain a Control Pump instead of the labeled Pressure Regulating Balloon component.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II medical device recall involves mislabeling that could result in the wrong component being used. No illnesses or injuries have been reported, fitting the rubric criteria for High (3): risk-of-harm products where injury has not yet been reported.
Plain-English summary
Boston Scientific Corporation is recalling 52 units of AMS Artificial Urinary Sphincter Pressure Regulating Balloons due to mislabeled packaging. Devices labeled as UPN 72400024 (Pressure Regulating Balloon, 61-70 cm H2O) may instead contain a Control Pump (UPN 72400098).
The affected lot numbers are 32500739, 32500821, and 32500820. The recall affects 15 U.S. states and 20 international countries and territories worldwide.
Patients and healthcare providers with potentially affected devices should contact Boston Scientific Corporation to verify the contents of their devices. Specific serial numbers have been identified to locate affected units.
The recalled product
- Product
- AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O
- Manufacturer
- Boston Scientific Corporation
- Hazard
- mis-labeling
- device-substitution
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UPN Number: 72400024. GTIN Number: 00878953000626. Lot Numbers: 32500739
- 32500821
- 32500820. Serial Numbers: 1100366088
- 1100366115
- 1100366089
- 1100366116
- 1100366090
- 1100366117
- 1100366091
- 1100366118
- 1100366092
- 1100366119
- 1100366093
- 1100366120
- 1100366094
- 1100366121
- 1100366095
- 1100366122
- 1100366096
- 1100366123
Distribution
Distributed nationwide across the United States.
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