AMS 800 Artificial Urinary Sphincter recallZ-0530-2025 · Boston Scientific Corporation · initiated Oct 28, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Error in labeling
What the company is doing
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).
Recall details
- Recall number
- Z-0530-2025
- Status
- Open, Classified
- Initiated by the company
- Oct 28, 2024
- Posted by the FDA
- Nov 25, 2024
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 16 units
- Product code
- EZY
- FDA submissions
- P000053
- 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 description
AMS Artificial Urinary Sphincter Control Pump
Code information (models, lots, serial numbers)
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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- AMS 800 Artificial Urinary Sphincter 72400098Boston Scientific Corporation · Device, Incontinence, Mechanical/Hydraulic1 recall137 reports
Product lines
Other devices under the same FDA submission
30 devices cleared under P000053 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- AMS 800 Artificial Urinary Sphincter 72404130Boston Scientific Corporation · Device, Incontinence, Mechanical/Hydraulic1 death1,803 reports
- AMS 800 Artificial Urinary Sphincter 72404131Boston Scientific Corporation · Device, Incontinence, Mechanical/Hydraulic1,394 reports
- AMS 800 Artificial Urinary Sphincter 72400024Boston Scientific Corporation · Device, Incontinence, Mechanical/Hydraulic1 recall1 death999 reports
- AMS 800 Artificial Urinary Sphincter 720157-01Boston Scientific Corporation · Device, Incontinence, Mechanical/Hydraulic591 reports
- AMS 800 Artificial Urinary Sphincter 72404132Boston Scientific Corporation · Device, Incontinence, Mechanical/Hydraulic576 reports
- AMS 800 Artificial Urinary Sphincter 72400160Boston Scientific Corporation · Device, Incontinence, Mechanical/Hydraulic487 reports
- AMS 800 Artificial Urinary Sphincter 72404127Boston Scientific Corporation · Device, Incontinence, Mechanical/Hydraulic443 reports
- AMS 800 Artificial Urinary Sphincter 72400161Boston Scientific Corporation · Device, Incontinence, Mechanical/Hydraulic358 reports
- AMS 800 Artificial Urinary Sphincter 72404133Boston Scientific Corporation · Device, Incontinence, Mechanical/Hydraulic220 reports
- AMS 800 Artificial Urinary Sphincter 72400162Boston Scientific Corporation · Device, Incontinence, Mechanical/Hydraulic111 reports
- AMS 800 Artificial Urinary Sphincter 720133-01Boston Scientific Corporation · Device, Incontinence, Mechanical/Hydraulic99 reports
- AMS 800 Artificial Urinary Sphincter 72404134Boston Scientific Corporation · Device, Incontinence, Mechanical/Hydraulic82 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 95608).
- Z-0531-2025 · Open, ClassifiedAMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page