PMA · Approved
Recalled · Class II · 2024Ams Sphincter 800 Urinary Control System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · EZY Device, Incontinence, Mechanical/Hydraulic
Approved on Jun 14, 2001 through premarket approval, which rests on the device’s own clinical evidence after a 177-day review. It has been recalled 6 times.
- Decided
- Jun 14, 2001
- Review
- 177 days
- Class
- Class III
- Product code
- EZY
- Recalls
- 6
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P000053 has 135 supplements since 2003: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2003 | 1 |
| 2004 | 3 |
| 2006 | 2 |
| 2007 | 6 |
| 2008 | 6 |
| 2009 | 7 |
| 2010 | 6 |
| 2011 | 4 |
| 2012 | 8 |
| 2013 | 2 |
| 2014 | 4 |
| 2015 | 8 |
| 2016 | 13 |
| 2017 | 12 |
| 2018 | 12 |
| 2019 | 10 |
| 2020 | 10 |
| 2021 | 2 |
| 2022 | 6 |
| 2023 | 4 |
| 2024 | 3 |
| 2025 | 4 |
| 2026 | 2 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EZY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 28, 2024 | Class II | Z-0531-2025 | Error in labeling | Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098) |
| Oct 28, 2024 | Class II | Z-0530-2025 | Error in labeling | Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098) |
| Jul 19, 2019 | Class II | Z-2442-2019 | Error in labeling | Mislabled: AMS 800 occlusive cuff labeled as 4.5 cm was a length of 4.0 cm and therefore.. |
| Mar 1, 2013 | Class II | Z-1280-2013 | Release of Material/Component prior to receiving test results | American Medical Systems, Inc. is initiating a recall on two components of the AMS 800¿ Urinary Control System, Control Pump & Pressure-Regulating Balloon. These products were released despite not meeting all final product release criteria. |
| Mar 1, 2013 | Class II | Z-1279-2013 | Release of Material/Component prior to receiving test results | American Medical Systems, Inc. is initiating a recall on two components of the AMS 800¿ Urinary Control System, Control Pump & Pressure-Regulating Balloon. These products were released despite not meeting all final product release criteria. |
| May 9, 2011 | Not classified | Z-2669-2011 | Nonconforming Material/Component | American Medical Systems is recalling all unexpired AMS 800 and AMS Acticon Neosphincter Control Pumps. Based upon a review of our product test procedures, we are unable to confirm that all Control Pumps have met our requirements. Test… |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All EZY devicesEZY Device, Incontinence, Mechanical/Hydraulic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EZY
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EZY
Too few EZY 510(k)s in any year since 2007 to give a median.
Recalls per year · EZY
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EZY
2,066in 2025
MAUDE reports naming product code EZY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | — | 0 | 7 |
| 2008 | 6 | — | 0 | 2 |
| 2009 | 7 | — | 0 | 14 |
| 2010 | 6 | — | 0 | 25 |
| 2011 | 4 | — | 1 | 26 |
| 2012 | 8 | — | 0 | 23 |
| 2013 | 2 | — | 0 | 22 |
| 2014 | 4 | — | 0 | 9 |
| 2015 | 9 | — | 0 | 13 |
| 2016 | 14 | — | 0 | 6 |
| 2017 | 12 | — | 0 | 9 |
| 2018 | 12 | — | 0 | 873 |
| 2019 | 10 | — | 0 | 2,753 |
| 2020 | 10 | — | 0 | 1,743 |
| 2021 | 3 | — | 1 | 1,697 |
| 2022 | 6 | — | 0 | 1,553 |
| 2023 | 4 | — | 0 | 1,778 |
| 2024 | 3 | — | 2 | 2,110 |
| 2025 | 6 | — | 0 | 2,066 |
| 2026 | 4 | — | 0 | — |
https://510kreport.com/device/P000053 · printed Nov 6, 2026
Cite this page
510(k) Report. “P000053: Ams Sphincter 800 Urinary Control System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P000053
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026