HIGH

Boston Scientific Recalls TENACIO Pumps Over Inflation Issues

Boston Scientific recalled 172 units of its CXR Preconnect with TENACIO Pump on September 11, 2025. The recall stems from potential inflation and deflation performance issues. The devices were distributed worldwide, including the US and Canada.

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 include UPNs: 72404461 (12CM PS IZ), 72404462 (14CM PS IZ), 72404463 (16CM PS IZ), 72404464 (18CM PS IZ), and 72404465 (10CM IP IZ). The pumps were distributed worldwide, including the US and Canada.

The Hazard

The pumps may experience inflation and deflation performance issues. This could compromise their effectiveness in medical applications, posing significant health risks.

Reported Incidents

No specific incidents were reported. The recall is classified as Class II, indicating a potential for serious health risks.

What to Do

Patients and healthcare providers should stop using the devices immediately. Contact Boston Scientific or your healthcare provider for further instructions.

Contact Information

For more information, visit Boston Scientific's website or the FDA recall link. Contact your healthcare provider for guidance.

Key Facts

  • Recall Date: September 11, 2025
  • Report Date: October 22, 2025
  • Quantity Recalled: 172 units
  • Distribution: Worldwide
  • Classification: Class II
View Original Recall on FDA - Medical Devices

Get Alerts for Health & Personal Care Recalls

Get notified about recalls in categories you care about.

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
1. UPN: 72404461 (12CM PS IZ)
UDI-DI: 00191506021504
Lot numbers: 1100398868
1100398869
1100398870
+15 more
Affected States
ALL
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

Related Recalls

HIGH

Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-695-01 - Carton NDC [60687-695-11- Unit Dose]

CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.

SUCRALFATE
CGMP Deviations:
Read more