Recall Z-0530-2025

Boston Scientific Corporation · initiated October 28, 2024

Class II Open, Classified

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

AMS Artificial Urinary Sphincter Control Pump

Codes / lots: 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

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: Error in labeling

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).

Details

Recall number
Z-0530-2025
Initiated
October 28, 2024
Posted by FDA
November 25, 2024
Product code
EZY – Device, Incontinence, Mechanical/Hydraulic
Quantity
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, Czech Republic, Finland, France, Germany, Ireland, Netherlands, Poland, Puerto Rico, South Korea, Spain, Sweden, Switzerland, and Taiwan.
Recalling firm
Boston Scientific Corporation, Marlborough, MA

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-0531-2025 Class IIAMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2OPotential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024)… 10/28/2024Open, Classified