Z-0139-2026Class II

TENACIO Pump without InhibiZone; UPN: 72404420

Name: Z-0139-2026 TENACIO Pump without InhibiZone; UPN: 72404420
Creator: Boston Scientific Corporation
Published: 2025-09-11
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2025-09-11 / Open, Classified / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of TENACIO Pump without InhibiZone; UPN: 72404420 on 2025-09-11. FDA classified it as Class II and gives the reason as "The potential for devices to experience inflation and/or deflation performance issues or difficulties". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0139-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-11
Posted: 2025-10-10
Recalling firm: Boston Scientific Corporation
Product: TENACIO Pump without InhibiZone; UPN: 72404420;
Product code: JCW Prosthesis, Penis, Inflatable
Reason for recall: The potential for devices to experience inflation and/or deflation performance issues or difficulties.
Root cause tag: manufacturing process
FDA 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 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.
Quantity in commerce: 0 units
Distribution: Worldwide distribution - US Nationwide and the country of Canada.
Product codes and lots: UPN: 72404420; UDI-DI: Lot numbers: 1100720566, 1100720567, 1100720568;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0139-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0138-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-10
Z-0139-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-10
Z-0140-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-10
Z-0141-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-10
Z-0142-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-10
Z-0143-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-10
Z-0144-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-10

Product code JCW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)