Prosthesis, Penis, Inflatable
FDA adverse event reports and recall history for prosthesis, penis, inflatable (product code JCW), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 2,707
- Deaths
- 1
- Injuries
- 2,515
- Malfunctions
- 186
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2025-10-10Open, ClassifiedNonconforming Material/Component
TENACIO Pump with InhibiZone; UPN: 72404429;
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
- 2025-10-10Open, ClassifiedNonconforming Material/Component
TENACIO Pump without InhibiZone; UPN: 72404420;
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
- 2025-10-10Open, ClassifiedNonconforming Material/Component
CX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404486 (15CM IP), (2) 72404488 (21CM IP);
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
- 2025-10-10Open, ClassifiedNonconforming Material/Component
LGX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404405 (12CM IP), (2) 72404407 (18CM IP);
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
- 2025-10-10Open, ClassifiedNonconforming Material/Component
CX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404430 (12CM PS IZ), (2) 72404431 (15CM PS IZ), (3) 72404432 (18CM PS IZ), (4) 72404433 (21CM PS IZ), (5) 72404434 (24CM PS IZ), (6) 72404435 (12CM IP IZ), (7) 72404436 (15CM IP IZ), (8) 72404437 (18CM IP IZ), (9) 72404438 (21CM IP IZ), (10) 72404439 (24CM IP IZ);
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
- 2025-10-10Open, ClassifiedNonconforming Material/Component
CXR Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404461 (12CM PS IZ), (2) 72404462 (14CM PS IZ), (3) 72404463 (16CM PS IZ), (4) 72404464 (18CM PS IZ), (5) 72404465 (10CM IP IZ), (6) 72404466 (12CM IP IZ), (7) 72404467 (14CM IP IZ), (8) 72404468 (16CM IP IZ), (9) 72404469 (18CM IP IZ);
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
- 2025-10-10Open, ClassifiedNonconforming Material/Component
LGX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404450 (12CM PS IZ), (2) 72404451 (15CM PS IZ), (3) 72404452 (18CM PS IZ), (4) 72404453 (21CM PS IZ), (5) 72404455 (12CM IP IZ), (6) 72404456 (15CM IP IZ), (7) 72404457 (18CM IP IZ), (8) 72404458 (21CM IP IZ);
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
- 2020-11-06Open, ClassifiedProcess control
AMS 700 MS Pump with and without InhibiZone, sold as individual units and also pre-connected to AMS 700 cylinders. Inflatable Penile Prosthesis
The 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 has difficulty activating the pump in order to achieve cylinder inflation.
- 2020-01-28TerminatedMixed-up of materials/components
AMS 700 100 mL, Spherical Reservoir with InhibiZone, Part No. 72404156 - Product Usage: intended for use in the treatment of chronic, organic, male erectile dysfunction (impotence).
A labeling discrepancy incorrectly labeled AMS 700 100mL Conceal Low Profile Reservoir with InhibiZone as 100mL Spherical Reservoir with InhibiZone.
- 2014-11-13TerminatedNonconforming Material/Component
AMS 700 Series Inflatable Penile Prosthesis Accessory Kit (AMS 700 Line Accessory Kit), 72401850. Keith Needles are part of the AMS 700 Accessory Kit. In conjunction with the Furlow Insertion Tool (Furlow), the Keith Needles facilitate the passing of the pulling sutures through the glans to place the AM3-700 cylinders in the corpus cavernosa.
AMS' supplier has issued a recall of certain lots of Lightning Bolt Keith needles supplied in AMS 700 Accessory Kits. Based on this, AMS is recalling AMS 700 Accessory Kits which contain these lots of needles. The supplier made the decision to issue this recall after an internal investigation that was requested by AMS. The investigation identified a potential nonconformity that may lead to a bent or broken Keith Needle when used with the Furlow tool.
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