HIGH

Boston Scientific Recalls CX Preconnect Pump Over Performance Issues

Boston Scientific recalled one CX Preconnect with TENACIO Pump due to inflation and deflation performance issues. The recall affects models UPN 72404486 and UPN 72404488 distributed in the US and Canada. The recall was issued on September 11, 2025, and remains active as of October 22, 2025.

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 models are UPN 72404486 (15CM IP) and UPN 72404488 (21CM IP). The units have UDI-DI numbers 00191506021658 and 00191506021672, respectively. They were distributed worldwide, including the US and Canada.

The Hazard

The CX Preconnect Pump may experience issues with inflation and deflation performance. This malfunction can pose significant risks, including inadequate fluid delivery.

Reported Incidents

No specific incidents or injuries have been reported at this time. However, the potential for performance issues raises concerns regarding patient safety.

What to Do

Stop using the device immediately. Follow the recall instructions provided by Boston Scientific or consult your healthcare provider for further guidance.

Contact Information

For more information, contact Boston Scientific Corporation. Visit their website or call their customer service line.

Key Facts

  • Recall affects CX Preconnect with TENACIO Pump
  • Models UPN 72404486 and UPN 72404488 included
  • Stop using the device immediately
  • Contact Boston Scientific for instructions
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 TypeInflation/Deflation Pump
Sold At
Multiple Retailers

Product Details

Model Numbers
1. UPN: 72404486 (15CM IP)
UDI-DI: 00191506021658
Lot numbers: 1100676851
1100676852
2. UPN: 72404488 (21CM IP)
+2 more
Affected States
ALL
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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