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 (CRT-P)
- Model numbers
- ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2 SL, ALTRUA 2 EL, VISIONIST, VALITUDE CRT-P EL, U125
- 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 and CRT-P devices regulate heart rhythm and heart function. They are implanted in patients to manage cardiac conditions.
Why This Is Dangerous
The recall centers on software that would enhance Safety Architecture and could prevent Safety Mode from activating when the device detects a high battery impedance state.
Industry Context
This recall is not presented as part of a broader industry pattern.
Real-World Impact
Patients with affected devices must stop using them and await manufacturer instructions. Clinician guidance will determine next steps, including potential device updates or replacements.
Practical Guidance
How to identify if yours is affected
- Identify if your device is in the ACCOLADE family or VISIONIST or VALITUDE CRT-P EL.
- Check device model numbers against the recall list: ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2 DR SL/EL, VISIONIST, VALITUDE CRT-P EL, U125.
- Review any recall letters mailed by the manufacturer.
Where to find product info
Refer to the FDA enforcement page and the Boston Scientific recall notices for detailed identifiers and instructions.
What timeline to expect
No specific timeline is provided. Follow the recall letter and clinician instructions.
If the manufacturer is unresponsive
- Consult your clinician for guidance.
- Contact Boston Scientific about the recall through the official channels and the FDA recall page.
How to prevent similar issues
- When considering cardiac rhythm devices, verify the specific model and software version.
- Monitor recall notices from the manufacturer and FDA for updates.
- Keep a record of all communications with clinicians and the manufacturer.
Documentation advice
Keep copy of recall letter, device model/serial numbers, and all correspondence with clinicians and the manufacturer.
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Product Details
Model numbers and device families affected include ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2 DR SL and DR EL, VISIONIST, and VALITUDE CRT-P EL. Worldwide distribution covers all markets where these devices are implanted. The recall date is 2025-08-20. 3,620 units are named in the notice. No specific price information is provided.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Devices: ACCOLADE family, VALITUDE CRT-P EL, VISIONIST
- Class I, HIGH hazard
- Recall notice date: 2025-08-20
- Manufacturer: Boston Scientific
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Safety Guide
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