Quick Facts at a Glance
- Recall Date
- August 20, 2025
- Hazard Level
- HIGH
- Brand
- Boston Scientific
- Category
- Health & Personal Care
- Sold At
- Unknown
- At-Risk Groups
- GENERAL, PREGNANT, PETS
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
- Pacemaker
- Model numbers
- U226, GTIN 00802526559457, 700333, 700335, 700342, 700344, 700346, 700347 +13 more
- Sold at
- Unknown
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 20, 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
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
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
Pacemakers implanted to regulate heart rhythm. They are life-sustaining for many patients and often require regular monitoring.
Why This Is Dangerous
Software upgrade intended to enhance Safety Architecture could prevent initiation of Safety Mode in ambulatory settings due to high battery impedance state.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
High risk to device performance; patients should follow clinician instructions and contact the manufacturer promptly.
Practical Guidance
How to identify if yours is affected
- Check device model U226 and listed codes.
- Review manufacturer recall notification letter.
- Consult with your clinician before any device changes.
Where to find product info
FDA recall page Z-0104-2026 and Boston Scientific patient safety communications.
What timeline to expect
Remediation timelines set by company and regulators; stay in contact with clinicians for updates.
If the manufacturer is unresponsive
- Document all attempts to contact the manufacturer and clinician
- Consider seeking assistance from hospital device liaison or patient advocacy group
- File a complaint with FDA if unresponsive
How to prevent similar issues
- Ensure device software is up to date per clinician instructions
- Maintain regular follow-up appointments
- Be aware of recall notices for implanted devices in your care
Documentation advice
Keep recall notification, device serial and model numbers, clinician correspondence
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Reported Incidents
No specific injuries or incidents are provided in the available data. The status is listed as HIGH hazard and Class I recall.
Key Facts
- Class I recall
- Devices affected: ACCOLADE family and Visionist/Valitude CRT-Ps
- Software to enhance Safety Architecture may prevent initiation of Safety Mode
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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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