Quick Facts at a Glance
- Recall Date
- August 20, 2025
- Hazard Level
- HIGH
- Brand
- Boston Scientific
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- At-Risk Groups
- GENERAL, ELDERLY
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
- L121 ESSENTIO DR EL Pacemaker, ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2 DR SL, ALTRUA 2 DR EL, VISIONIST, VALITUDE
- Sold at
- Multiple Retailers
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 regulate heart rhythm and are implanted devices monitored by clinicians. They are critical for patients with rhythm disorders and rely on software to manage safety features.
Why This Is Dangerous
The recall concerns software intended to enhance Safety Architecture. If the software fails to initiate Safety Mode during high battery impedance, it can compromise device safety in real-world use.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
Patients with affected devices may require medical follow-up or device replacement. The recall affects 10,833 units and has implications for clinical scheduling and patient safety.
Practical Guidance
How to identify if yours is affected
- Confirm device model against the recall list.
- Check device label and patient ID card for model and serial numbers.
- Consult your cardiology team if you are unsure whether your device is affected.
Where to find product info
Details are available on the FDA recall page and through your healthcare provider. Look for model numbers and serials on hospital records and device labels.
What timeline to expect
Replacements and next steps are coordinated through healthcare providers. Timelines vary by patient and hospital capacity.
If the manufacturer is unresponsive
- Document all attempts to contact the provider
- Contact the hospital patient safety office
- If necessary, report through the FDA recall process.
How to prevent similar issues
- Keep medical documents up to date
- Ask providers about software updates and safety recalls during visits
- Ensure you have access to your device ID and recall notices
Documentation advice
Maintain copies of all recall communications, hospital correspondence, and any scheduling notices. Document any device-related symptoms and medical consultations
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Product Details
Brand: Boston Scientific. Model numbers include ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2 DR SL, ALTRUA 2 DR EL, VISIONIST, VALITUDE. Sold worldwide through hospitals and medical distributors. Price and sale dates not disclosed. Volume recalled: 10,833 units.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Devices affected: ACCOLADE family, PROPONENT, ESSENTIO, ALTRUA 2 (DR SL/SL EL), VISIONIST, VALITUDE
- Hazard level: Class I
- No injuries reported
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