Z-0531-2025Class II

AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O

Name: Z-0531-2025 AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O
Creator: Boston Scientific Corporation
Published: 2024-10-28
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2024-10-28 / Open, Classified / root cause: labeling and UDI

FDA source

Boston Scientific Corporation began a recall of AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O on 2024-10-28. FDA classified it as Class II and gives the reason as "Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0531-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-10-28
Posted: 2024-11-25
Recalling firm: Boston Scientific Corporation
Product: AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O
Product code: EZY Device, Incontinence, Mechanical/Hydraulic
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)
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: 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).
Quantity in commerce: 52 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.
Product codes and lots: 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, 1100366097, 1100366144, 1100366098, 1100366145, 1100366099, 1100366146, 1100366100, 1100366147, 1100366101, 1100366148, 1100366102, 1100366149, 1100366103, 1100366150, 1100366104, 1100366151, 1100366105, 1100366152, 1100366106, 1100366153, 1100366107, 1100366154, 1100366108, 1100366155, 1100366109, 1100366156, 1100366110, 1100366157, 1100366111, 1100366158, 1100366112, 1100366159, 1100366113, 1100366160, 1100366114. Expiration Date: 09/23/2028

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0531-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0530-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-04	2024-11-25
Z-0531-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-04	2024-11-25

Product code EZY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)