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, 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
- Implantable Pacemaker
- Model numbers
- GTIN 00802526559082, 100002, 100009, 100010, 100011, 100012, 100014, 100017 +12 more
- 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 devices that regulate heart rhythms. The ACCOLADE family, PROPONENT, ESSENTIO, ALTRUA 2 DR, and CRT-Ps like VISIONIST and VALITUDE are designed to manage heart pacing and synchronization.
Why This Is Dangerous
A software flaw in Safety Architecture could prevent the device from entering Safety Mode when needed due to high battery impedance, potentially compromising patient safety.
Industry Context
This recall reflects a pattern where software controls in implantable devices affect safety features. It is not described as part of a broader industry recall in the data provided.
Real-World Impact
Patients may need urgent medical evaluation and device monitoring. The recall requires clinicians to reassess device safety and consider replacement or alternative management.
Practical Guidance
How to identify if yours is affected
- Check device model against ACCOLADE family and CRT-Ps listed in recall materials
- Review GTIN 00802526559082 for device identification
Where to find product info
Refer to the FDA enforcement recall page and Boston Scientific patient resources for device identifiers and instructions
What timeline to expect
Remedies and replacements are typically processed over weeks to months depending on the case
If the manufacturer is unresponsive
- Escalate to hospital risk management
- Consult patient advocacy groups or clinicians for escalation
- File a formal complaint with the FDA if needed
How to prevent similar issues
- Verify device firmware updates with clinicians
- Keep all recall notices accessible
- Ensure device monitoring plans are in place with healthcare providers
Documentation advice
Save recall letters, maintain a log of communications with clinicians and manufacturers, preserve serial numbers and GTINs, document any adverse events
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Product Details
Brand: Boston Scientific Product: ACCOLADE family pacemakers, PROPONENT, ESSENTIO, ALTRUA 2 DR SL/EL pacemakers; VISIONIST CRT-Ps; VALITUDE CRT-Ps GTIN: 00802526559082 Serial Numbers: 100002, 100009, 100010, 100011, 100012, 100014, 100017, 100020, 100021, 100023, 100024, 100026, 100029, 100034, 100037, 100038, 100040, 100041, 100045 Sold through: Worldwide distribution to healthcare providers Sold since: Unknown Price: Unknown
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 41,009 units recalled worldwide
- Affects ACCOLADE family and VISIONIST/VALITUDE CRT-P devices
- GTIN 00802526559082 and 19 listed serial numbers
- Recall date 2025-08-20; status ACTIVE
- Hazard: software could impede Safety Mode activation
- Immediate action required: stop using the device and contact healthcare provider
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Safety Guide
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