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
- CX Preconnect with TENACIO Pump
- Model numbers
- UPN: 72404486 (15CM IP), UDI-DI: 00191506021658, Lot numbers: 1100676851, Lot numbers: 1100676852, UPN: 72404488 (21CM IP), UDI-DI: 00191506021672, Lot number: 1100717673
- Sizes
- 15CM IP, 21CM 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 a CX Preconnect with TENACIO Pump used in clinical settings to assist device inflation. It was distributed worldwide to healthcare providers, including the US and Canada.
Why This Is Dangerous
The device may fail to inflate or deflate correctly, potentially impacting procedure outcomes or device effectiveness.
Industry Context
This recall is not described as part of a broader industry pattern in the provided notice.
Real-World Impact
The recall may cause procedural delays or require device replacement to maintain treatment efficacy.
Practical Guidance
How to identify if yours is affected
- Check UPNs 72404486 and 72404488 against your inventory.
- Consult recall materials for replacement or removal instructions.
Where to find product info
Official recall details are on the FDA recall page linked in the notice and the manufacturer communications.
What timeline to expect
Remedy processes for medical device recalls vary; follow manufacturer guidance and FDA notices. Expect processing steps to take weeks.
If the manufacturer is unresponsive
- Escalate to hospital risk management or device procurement departments.
- Contact FDA recall helpline if manufacturer information is slow to respond.
How to prevent similar issues
- Verify device components and lot numbers before use.
- Maintain up-to-date recall lists for all inflator/deflator devices.
- Consult manufacturer for InhibiZone-enabled alternatives if applicable.
Documentation advice
Retain all recall notices, labeling, and correspondence. Photograph device labels showing UPN, UDI-DI, and lot numbers.
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Product Details
UPN 72404486 (15CM IP) UDI-DI 00191506021658; Lot numbers 1100676851, 1100676852. UPN 72404488 (21CM IP) UDI-DI 00191506021672; Lot number 1100717673. Worldwide distribution to healthcare providers, including the United States and Canada. Recall date 2025-09-11.
Reported Incidents
No injuries or incidents have been reported.
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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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