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
- INFANTS, CHILDREN, 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
- GTIN 00802526558924, Serial Numbers: 100056, 100092, 100111, 100120, 100122, 100125, 100127, 100134, 100136, 100137, 100142, 100144, 100147, 100154, 100156, 100160, 100161, 100162, 100168
- 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 are implanted devices that regulate heart rhythm. The ACCOLADE family includes several models used for bradycardia support and CRT-P therapy.
Why This Is Dangerous
A software issue could prevent initiation of Safety Mode in high impedance battery conditions, potentially compromising device safety functions.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Patients may experience safety mode failures requiring medical oversight and possible device replacement; action is urgent due to high hazard.
Practical Guidance
How to identify if yours is affected
- Check the device model and serial number against the recall list.
- Verify the device is within the affected ACCOLADE family and CRT-P devices VISIONIST or VALITUDE.
- Consult your clinician for device status.
Where to find product info
Serial numbers and GTIN are listed in recall communications and FDA enforcement reports.
What timeline to expect
No specific timeline provided beyond recall issuance; patients should follow provider guidance.
If the manufacturer is unresponsive
- Escalate to patient advocacy or hospital biomedical engineering department
- File formal inquiries with Boston Scientific and await response
How to prevent similar issues
- Regularly review device recalls issued by FDA for cardiac devices
- Maintain updated clinician contact for device management
- Record serial numbers and keep documentation for future recalls
Documentation advice
Keep all recall communications, serial numbers, device ID, and clinician notes.
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Product Details
Brand: Boston Scientific. Product: ACCOLADE family pacemakers (ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2 DR SL and DR EL) and VISIONIST and VALITUDE CRT-Ps. Model identifiers include GTIN 00802526558924 and serial numbers such as 100056, 100092, 100111, 100120, 100122, 100125, 100127, 100134, 100136, 100137, 100142, 100144, 100147, 100154, 100156, 100160, 100161, 100162, 100168. Distribution: Worldwide. Recall date: 2025-08-20. Status: Active.
Reported Incidents
No specific incident counts or injuries are provided in the documentation. The hazard is described but no injury data is included.
Key Facts
- Hazard level: HIGH
- Model/serial identifiers include GTIN 00802526558924 and listed serials
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Safety Guide
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