HIGH

Boston Scientific Recalls TENACIO Pump Over Deflation Issues

Boston Scientific recalled 59 units of the TENACIO Pump with InhibiZone on September 11, 2025. The recall addresses potential inflation and deflation performance issues. Patients should stop using the device immediately and follow the manufacturer's instructions.

Quick Facts at a Glance

Recall Date
September 11, 2025
Hazard Level
HIGH
Brand
Boston Scientific
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

The potential for devices to experience inflation and/or deflation performance issues or difficulties.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Boston Scientific Corporation or your healthcare provider for instructions. Notification method: Letter

Product Details

The recalled product is the TENACIO Pump with InhibiZone, UPN: 72404429. It was distributed worldwide, including the United States and Canada.

The Hazard

The recall warns of potential inflation and deflation performance issues. These issues can affect the device's effectiveness.

Reported Incidents

No specific incidents or injuries have been reported at this time. The risk level is classified as high.

What to Do

Stop using the pump immediately. Follow the recall instructions provided by Boston Scientific Corporation or contact your healthcare provider for further guidance.

Contact Information

For further instructions, contact Boston Scientific Corporation. Their website is available for additional information.

Key Facts

  • Recalled product: TENACIO Pump with InhibiZone
  • Recall date: September 11, 2025
  • Quantity recalled: 59 units
  • Distribution: US Nationwide and Canada
  • Class II recall due to performance issues
View Original Recall on FDA - Medical Devices

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypePump
Sold At
Multiple Retailers

Product Details

Model Numbers
UPN: 72404429
UDI-DI: Lot numbers: 1100551131
1100551132
1100551134
1100551135
+15 more
Affected States
ALL
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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