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U.S. Department of Health and Human Services

Class 2 Device Recall AMS Artificial Urinary Sphincter Control Pump

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 Class 2 Device Recall AMS Artificial Urinary Sphincter Control Pumpsee related information
Date Initiated by FirmOctober 28, 2024
Date PostedNovember 25, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0530-2025
Recall Event ID 95608
PMA NumberP000053 
Product Classification Device, incontinence, mechanical/hydraulic - Product Code EZY
ProductAMS Artificial Urinary Sphincter Control Pump
Code Information UPN Number: 72400098. GTIN Number: 00878953000688. Lot Number: 32487464. Serial Numbers: 1100366307, 1100366316, 1100366309, 1100366317, 1100366310, 1100366319, 1100366311, 1100366320, 1100366312, 1100366321, 1100366313, 1100366323, 1100366314, 1100366324, 1100366315, 1100366325. Expiration Date: 09/24/2028
Recalling Firm/
Manufacturer
Boston Scientific Corporation
100 Boston Scientific Way
Marlborough MA 01752-1234
For Additional Information ContactRenee Archie
508-683-4000
Manufacturer 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)
FDA Determined
Cause 2
Error in labeling
ActionBoston 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).
Quantity in Commerce16 units
DistributionWorldwide - 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, Czech Republic, Finland, France, Germany, Ireland, Netherlands, Poland, Puerto Rico, South Korea, Spain, Sweden, Switzerland, and Taiwan.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA DatabasePMAs with Product Code = EZY
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