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, INFANTS, PREGNANT
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 00802526559006, Serial Numbers: 102138, 102172, 102192, 102209, 102210, 102229, 102231 +12 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 and CRT-Ps regulate heart rhythms for patients with heart conditions. They are implanted devices requiring ongoing monitoring and follow-up.
Why This Is Dangerous
A software flaw could prevent Safe Mode activation in high impedance battery states, reducing protective safety features.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Immediate action is required by patients and providers to align with official guidance and protect patient safety.
Practical Guidance
How to identify if yours is affected
- Check device model against recall list: ACCOLADE family, VISIONIST, VALITUDE CRT-Ps.
- Consult implanting physician or device clinic for confirmation.
Where to find product info
Manufacturer recall notice, patient letter, and FDA enforcement report linked in recall page.
What timeline to expect
Remedies and next steps are determined by the manufacturer; patients should expect guidance from healthcare providers.
If the manufacturer is unresponsive
- Document all communications with healthcare providers.
- If manufacturer is slow, contact the hospital's device clinic for escalation.
How to prevent similar issues
- Ensure device software updates come through official channels.
- Regular follow-up appointments for device checks.
- Avoid tampering with device software.
- Stay informed through FDA and manufacturer notices.
Documentation advice
Keep copy of recall notice, serial numbers, physician notes, and any correspondence with provider.
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Product Details
Brand: Boston Scientific. Product: ACCOLADE family pacemakers and VISIONIST/VALITUDE CRT-P devices. Model: ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2 DR SL and DR EL, VISIONIST, VALITUDE. GTIN/Serials: GTIN 00802526559006; Serial Numbers include: 102138, 102172, 102192, 102209, 102210, 102229, 102231, 102232, 102233, 102237, 102239, 102243, 102255, 102256, 102261, 102263, 102265, 102266, 102267. Quantity: 34,180 units. Distribution: Worldwide. Recall date: 2025-08-20. Status: Active.
Reported Incidents
No specific injury or incident counts are provided in the recall notice. The hazard level is classified as HIGH.
Key Facts
- Active recall as of 2025-10-22
- High hazard level
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