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, 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
- Cardiac Pacemaker
- Model numbers
- L131, GTIN 00802526559266, Serial Numbers: 102068, 102071, 102072, 102074, 102086, 102089 +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 regulate heart rhythm in patients with arrhythmias and are implanted devices monitored by clinicians.
Why This Is Dangerous
A software update intended to enhance Safety Architecture could prevent activation of Safety Mode when battery impedance is high, potentially compromising safety.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients may require clinician-directed actions, including monitoring or device replacement, with significant medical implications if unsettled.
Practical Guidance
How to identify if yours is affected
- Confirm device family and model (ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2 DR SL/EL, VISIONIST, VALITUDE)
- Check serial numbers against the recall list (e.g., 102068, 102071, 102072, 102074, etc.)
- Consult your cardiologist or device sponsor immediately if affected
- Do not attempt to modify the device yourself
Where to find product info
Serial numbers appear on the device, its packaging, and patient card; GTIN appears on packaging
What timeline to expect
Not specified by the manufacturer
If the manufacturer is unresponsive
- Document attempts to contact the manufacturer and your provider
- File a recall complaint with FDA if advised
- Seek alternatives through your clinician promptly
How to prevent similar issues
- Register for recall alerts from the manufacturer
- Keep clinician contact information up to date
- Only follow manufacturer-issued software changes under medical supervision
- Be vigilant for recall notices in mail or email
Documentation advice
Keep all recall letters, device serial numbers, packaging photos, and communication records with providers and the company
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Product Details
Model Number: L131, ESSENTIO DR EL MRI Pacemaker. Quantity: 190,088 units. Distribution: Worldwide. GTIN: 00802526559266. Serial Numbers: 102068, 102071, 102072, 102074, 102086, 102089, 102091, 102092, 102094, 102095, 102097, 102101, 102102, 102104, 102108, 102115, 102120, 102122, 102124. Includes ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2 dual chamber SL and EL DR devices, and VISIONIST and VALITUDE CRT-Ps.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Devices affected include ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2 DR SL/EL, VISIONIST and VALITUDE
- Hazard level: HIGH
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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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