AMS 700 LGX TENACIO Pump recallZ-0141-2026 · Boston Scientific Corporation · initiated Sep 11, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-0141-2026
- Status
- Open, Classified
- Initiated by the company
- Sep 11, 2025
- Posted by the FDA
- Oct 10, 2025
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 0 units
- Product code
- JCW
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
Product description
LGX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404405 (12CM IP), (2) 72404407 (18CM IP);
Code information (models, lots, serial numbers)
1. UPN: 72404405 (12CM IP); UDI-DI: 00191506021252; Lot numbers: 1100687060, 1100687061; 2. UPN: 72404407 (18CM IP); UDI-DI: 00191506021276; Lot numbers: 1100676894, 1100676895;
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- AMS 700 LGX™ TENACIO™ Pump 72404405Boston Scientific Corporation · Prosthesis, penis, inflatable1 recall0 reports
- AMS 700 LGX™ TENACIO™ Pump 72404407Boston Scientific Corporation · Prosthesis, penis, inflatable1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 97603).
- Z-0140-2026 · Open, ClassifiedCX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404486 (15CM IP), (2) 72404488 (21CM IP);
- Z-0142-2026 · Open, ClassifiedCX 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…
- Z-0143-2026 · Open, ClassifiedCXR 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) 7240446…
- Z-0144-2026 · Open, ClassifiedLGX 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) 7240445…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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