Recall Z-0142-2026
Boston Scientific Corporation · initiated September 11, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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);
Codes / lots: 1. UPN: 72404430 (12CM PS IZ); UDI-DI: 00191506021313; Lot numbers: 1100489479, 1100489482, 1100553932, 1100553938, 1100553939, 1100559594, 1100568472, 1100592190, 1100592195, 1100602356, 1100602384, 1100604224, 1100604257, 1100604936, 1100667673, 1100667677, 1100691423, 1100523050, 1100489473, 1100489476, 1100559588, 1100568474, 1100546165, 1100568477, 1100523054, 1100568478, 1100559592, 1100489475, 1100559590, 1100546163, 1100572777, 1100546162, 1100523055, 1100568476, 1100553937, 1100546160, 1100572771, 1100572772, 1100559595, 1100489478, 1100553936, 1100523051, 1100572769, 1100489477, 1100523049, 1100546159, 1100489474, 1100572773, 1100546164, 1100604225, 1100602381, 1100602351, 1100592189, 1100604227, 1100602383, 1100602379, 1100592191, 1100604262, 1100604260, 1100592196, 1100604259, 1100667670, 1100670795, 1100670801, 1100667671, 1100667679, 1100667678, 2. UPN: 72404431 (15CM PS IZ); UDI-DI: 00191506021320; Lot numbers: 1100488945, 1100488946, 1100488947, 1100488951, 1100488952, 1100488953, 1100488954, 1100488981, 1100488982, 1100488983, 1100488984, 1100509688, 1100509689, 1100509690, 1100509693, 1100509694, 1100509695, 1100509706, 1100509711, 1100509714, 1100509716…
Reason for recall
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
FDA-determined cause: Nonconforming Material/Component
Action taken
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 organization where the potentially affected devices have been transferred. Please provide Boston Scientific with details of any affected devices that have been transferred to another organization.
Details
- Recall number
- Z-0142-2026
- Initiated
- September 11, 2025
- Posted by FDA
- October 10, 2025
- Product code
- JCW – Prosthesis, Penis, Inflatable
- Quantity
- 2288 units
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Recalling firm
- Boston Scientific Corporation, Marlborough, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0138-2026 Class II | TENACIO Pump with InhibiZone; UPN: 72404429;The potential for devices to experience inflation and/or deflation performance issues or difficulties. | 09/11/2025Open, Classified |
| Z-0139-2026 Class II | TENACIO Pump without InhibiZone; UPN: 72404420;The potential for devices to experience inflation and/or deflation performance issues or difficulties. | 09/11/2025Open, Classified |
| Z-0140-2026 Class II | CX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404486 (15CM IP), (2)…The potential for devices to experience inflation and/or deflation performance issues or difficulties. | 09/11/2025Open, Classified |
| Z-0141-2026 Class II | LGX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404405 (12CM IP), (2)…The potential for devices to experience inflation and/or deflation performance issues or difficulties. | 09/11/2025Open, Classified |
| Z-0143-2026 Class II | CXR Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404461 (12CM PS IZ)…The potential for devices to experience inflation and/or deflation performance issues or difficulties. | 09/11/2025Open, Classified |
| Z-0144-2026 Class II | LGX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404450 (12CM PS IZ)…The potential for devices to experience inflation and/or deflation performance issues or difficulties. | 09/11/2025Open, Classified |