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AMS 700 CX

BOSTON SCIENTIFIC CORPORATION · Model 72404174 · UDI-DI 00878953003283

JCW Prescription
0
510(k) clearances
2,834
Adverse events (1 deaths)
19
Recalls
4
Facilities

Description

Inflatable Penile Prosthesis, 2 Cylinders, InhibiZone treated

Recalls

DateFirmReason
2025-09-11Boston Scientific CorporationThe potential for devices to experience inflation and/or deflation performance issues or difficulties.
2025-09-11Boston Scientific CorporationThe potential for devices to experience inflation and/or deflation performance issues or difficulties.
2025-09-11Boston Scientific CorporationThe potential for devices to experience inflation and/or deflation performance issues or difficulties.
2025-09-11Boston Scientific CorporationThe potential for devices to experience inflation and/or deflation performance issues or difficulties.
2025-09-11Boston Scientific CorporationThe potential for devices to experience inflation and/or deflation performance issues or difficulties.
2025-09-11Boston Scientific CorporationThe potential for devices to experience inflation and/or deflation performance issues or difficulties.
2025-09-11Boston Scientific CorporationThe potential for devices to experience inflation and/or deflation performance issues or difficulties.
2021-03-26Boston Scientific CorporationAn AMS 700 100 mL Spherical Reservoir with InhibiZone was incorrectly labeled as a 100 mL Conceal Reservoir with InhibiZone.
2020-09-24Boston Scientific CorporationThe recalling firm has observed an increase in complaints of problems encountered during the initial activation of the device in which the patient and/or the physician is unable or
2019-12-17Boston Scientific CorporationA labeling discrepancy incorrectly labeled AMS 700 100mL Conceal Low Profile Reservoir with InhibiZone as 100mL Spherical Reservoir with InhibiZone.

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Data 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.