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AMS 800 Artificial Urinary Sphincter
BOSTON SCIENTIFIC CORPORATION · Model 72404144 · UDI-DI 00878953003191
EZY
Prescription
0
510(k) clearances
18,298
Adverse events (9 deaths)
7
Recalls
4
Facilities
Description
Occlusive Cuff with InhibiZone
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-10-28 | Boston Scientific Corporation | Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098) |
| 2024-10-28 | Boston Scientific Corporation | Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098) |
| 2021-11-22 | Uromedica Inc. | The U-channel sheaths may cause damage to ProACT implant devices when the devices are passed through the sheath during a ProACT implantation procedure. |
| 2019-07-19 | Boston Scientific Corporation | Mislabled: AMS 800 occlusive cuff labeled as 4.5 cm was a length of 4.0 cm and therefore.. |
| 2013-03-01 | American Medical Systems, Inc. | 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 rel |
| 2013-03-01 | American Medical Systems, Inc. | 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 rel |
| 2011-05-09 | American Medical Systems, Inc. | 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 confir |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.