Boston Scientific Corporation recalls TENACIO Pump with InhibiZone
Reason for recall
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
TENACIO Pump with InhibiZone; UPN: 72404429;
Lot / code information
- Lot #
1100551131, 1100551132, 1100551134, 1100551135, 1100551136, 1100551137 — +86 moreShow all
1100551131, 1100551132, 1100551134, 1100551135, 1100551136, 1100551137, 1100551139, 1100551145, 1100551149, 1100553579, 1100553580, 1100553582, 1100553583, 1100553584, 1100553585, 1100553586, 1100553588, 1100553589, 1100553590, 1100553591, 1100553594, 1100553595, 1100553596, 1100579593, 1100579596, 1100579598, 1100579599, 1100579600, 1100579639, 1100579640, 1100579642, 1100579643, 1100579646, 1100580141, 1100580143, 1100580144, 1100580145, 1100580146, 1100580149, 1100580598, 1100580599, 1100580600, 1100580601, 1100580605, 1100580608, 1100580609, 1100580610, 1100580612, 1100678770, 1100678774, 1100678775, 1100678776, 1100679129, 1100687128, 1100687130, 1100687133, 1100687134, 1100687135, 1100687140, 1100687142, 1100717769, 1100717773, 1100717774, 1100717775, 1100717776, 1100553592, 1100551147, 1100551138, 1100553597, 1100551146, 1100551142, 1100551148, 1100551141, 1100579595, 1100580147, 1100580606, 1100579641, 1100580607, 1100580595, 1100580603, 1100579601, 1100580148, 1100580597, 1100580596, 1100580613, 1100580611, 1100678777, 1100687129, 1100679130, 1100678773, 1100721233, 1100721238
What the firm 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.
DistributionShow detailsHide
Worldwide distribution - US Nationwide and the country of Canada.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-0138-2026
- FDA device classification · JCWOfficial FDA classification for this device type
- CFR regulation · 21 CFR 876.3350The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Boston Scientific CorporationSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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