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
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
- L231, GTIN 00802526559143, GTIN 00802526576423, GTIN 00802526578052
- 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 are implanted cardiac devices that regulate heart rhythm. The L231 model and ACCOLADE family serve dual-chamber pacing needs and, in some configurations, CRT-P therapy.
Why This Is Dangerous
Software intended to enhance safety features may fail to trigger Safety Mode during high battery impedance events, potentially compromising device safety.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
For patients, this recall means stopping use and seeking clinical guidance promptly. The impact hinges on device dependence and clinical status.
Practical Guidance
How to identify if yours is affected
- Identify if your device is L231 or part of the ACCOLADE family, VISIONIST or VALITUDE CRT-Ps.
- Review GTINs listed in the recall materials.
- Cross-check with your device ID card and clinician records.
Where to find product info
Recall notices from Boston Scientific and FDA enforcement communications list model numbers, GTINs, and corrective actions.
What timeline to expect
Remedies and replacement steps will be provided by the manufacturer through clinical channels; timelines vary by patient and device status.
If the manufacturer is unresponsive
- Escalate to your clinician and seek portable medical advice.
- Document all attempts to contact the manufacturer and your clinician.
How to prevent similar issues
- When buying or approving devices, verify MRI labeling and safety updates.
- Maintain regular follow-ups with your cardiologist.
- Follow any firmware or software updates issued through clinical channels.
Documentation advice
Record device model, GTINs, recall date, clinician instructions, and all correspondence with the manufacturer.
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Product Details
Model numbers: L231. Device families affected: ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2 DR SL/EL; CRT-Ps VISIONIST and VALITUDE. Sold worldwide; recall date: August 20, 2025. GTINs: 00802526559143, 00802526576423, 00802526578052. Quantity: 63,851 units. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Software defect affects ACCOLADE family and VISIONIST/VALITUDE CRT-P devices
- Recall date: August 20, 2025
- Stop using device immediately
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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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