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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Boston Scientific
- Product type
- TENACIO Pump
- Model numbers
- UPN: 72404405 (12CM IP), UPN: 72404407 (18CM IP)
- Sizes
- 12CM IP, 18CM IP
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 11, 2025
Reported by FDA DEVICE
October 22, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
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
About This Product
This device is part of a patient support system used in clinical settings for inflation/deflation control. It is not a consumer-grade device.
Why This Is Dangerous
An inflation/deflation performance issue could compromise device function and patient safety by affecting timely inflation or deflation.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Immediate cessation of use is required. Delays in treatment could occur while awaiting guidance from the manufacturer.
Practical Guidance
How to identify if yours is affected
- Identify the affected UPNs 72404405 and 72404407
Where to find product info
UDI-DI numbers, lot numbers, and UPNs appear on device labeling and packaging.
What timeline to expect
Recall remedies or replacements, if offered, typically follow manufacturer guidance. Expect updates by letter.
If the manufacturer is unresponsive
- Document communication attempts
- Escalate to corporate recall contact
- Consult your healthcare facility recall coordinator
How to prevent similar issues
- Verify UDI-DI and lot numbers before use
- Only use devices from approved lots
- Keep up to date with recall announcements and manufacturer guidance
Documentation advice
Keep copies of recall notices, device labels, and all correspondence with the manufacturer
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Product Details
Model numbers and identifying details: UPN 72404405 (12CM IP) with UDI-DI 00191506021252; Lot numbers 1100687060, 1100687061. UPN 72404407 (18CM IP) with UDI-DI 00191506021276; Lot numbers 1100676894, 1100676895. Distribution: Worldwide distribution including US Nationwide and Canada. Sold as part of the LGX Preconnect system. Quantity: 0 units.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- UPN 72404405 (12CM IP) and UPN 72404407 (18CM IP) affected
- Recall date 2025-09-11; status ACTIVE
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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