Recall Z-0141-2026 ยท JCW Prosthesis, Penis, Inflatable
Boston Scientific Corporation
LGX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404405 (12CM IP), (2) 72404407 (18CM IP);
| Date | Oct 10, 2025 (initiated Sep 11, 2025) |
| Status | Open, Classified |
| Reason | The potential for devices to experience inflation and/or deflation performance issues or difficulties. |
| Root cause | Nonconforming Material/Component |
| Action | On September 11, 2025 URGENT MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken: For implanted devices: If the device is working properly, no action is required. Further evaluation is recommended for patients who were implanted with an affected device AND are having difficulty inflating or deflating the device. - Check inventory for affected product and return any unused devices. Immediately cease further distribution or use of any unused affected devices. Please pass this notice to any healthcare professional from your organization that needs to be aware and to any orga |
| Quantity | 0 units |
| Distribution | Worldwide distribution - US Nationwide and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.