Recall Z-0531-2025— Boston Scientific Corporation
Class II · Ongoing
Class II FDA medical device recall by Boston Scientific Corporation, initiated 2024-10-28. FDA's recall record names no specific 510(k) clearance for this event. Product: AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O. Reason: Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098).
- Recalling firm
- Boston Scientific Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-10-28
- Firm location
- Marlborough, MA, United States
Product description
AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O
Reason for recall
Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098)
Data sourced from openFDA. This site is unofficial and independent of the FDA.