CLASS II ONGOING Device recall · Reported 4 Dec 2024 · FDA Enforcement Report
AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61- H2O recalled
Boston Scientific is recalling AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61- H2O, distributed nationwide in the US. The recall was initiated on 28 Oct 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0531-2025
- FDA event ID
- 95608
- Recalling firm
- Boston Scientific, Marlborough, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 28 Oct 2024
- FDA classified
- 25 Nov 2024
- Reported
- 4 Dec 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Heart & Vascular Devices
Timeline
| 28 Oct 2024 | Recall initiated by company | |
| 25 Nov 2024 | Classified by FDA | +28 days |
| 4 Dec 2024 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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)
Product as listed by the FDA
AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O
Where it was distributed
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.
Nationwide ArizonaCaliforniaColoradoFloridaKansasLouisianaMassachusettsMichiganMinnesotaNew YorkOregonPennsylvaniaPuerto RicoTexasVirginiaWashington
Questions about this recall
Why was it 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)
Which lots are affected?
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
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 95608This product is part of a recall event; the main page for the event is AMS Artificial Urinary Sphincter Control Pump recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | AMS Artificial Urinary Sphincter Control Pump recalled | Boston Scientific | Labeling Errors | Nationwide |
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