AMS Artificial Urinary Sphincter Control Pump
FDA device recall Z-0530-2025 · posted 2024-11-25 · Open, Classified
Recall details
- Recalling firm
- Boston Scientific Corporation
- 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)
- Action taken
- Boston Scientific notified their consignees on about 10/28/2024 via letter. Consignees were instructed to immediately discontinue use and segregate the affected products, notify all personnel that need to be aware, notify customers if further distributed, arrange for the return of affected product and complete and return the Reply Verification Tracking Form (RVtF).
- Root cause
- Error in labeling
- Status
- Open, Classified
- Product code
- EZY
- Quantity affected
- 16 units
- Distribution
- Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, KS, LA, MA, MI, MN, NY, OR, PA, TX, VA, WA and the countries of Argentina, Australia, Austria, Belgium, Chile, China, Costa Rica
- Date initiated
- 2024-10-28
- Date posted
- 2024-11-25
- Location
- Marlborough, MA
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