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, 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
- S702, ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2 DR SL, ALTRUA 2 DR EL, VISIONIST, VALITUDE
- 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 provide heart rhythm support for patients with bradycardia or conduction disorders. They are implanted devices monitored by clinicians.
Why This Is Dangerous
Software intended to enhance Safety Architecture may fail to initiate Safety Mode in the presence of high battery impedance, potentially compromising device safety.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients may experience uncertainty and require urgent medical guidance.
Practical Guidance
How to identify if yours is affected
- Identify device model and serial numbers from the device label, patient records, or clinician notes
- Check recall notice for listed models and SKUs
- Contact healthcare provider for confirmation and instructions
Where to find product info
Recall notices and FDA enforcement report Z-0099-2026 linked to Boston Scientific devices
What timeline to expect
Official remediation timelines to be provided by Boston Scientific through patient and clinician communications
If the manufacturer is unresponsive
- Escalate to patient advocate groups
- File a report with the FDA if necessary
- Consult legal counsel if needed
How to prevent similar issues
- Ensure devices are monitored via remote monitoring where available
- Keep patient records up to date with device information
- Stay informed through official recalls and manufacturer notifications
Documentation advice
Document all communications with clinicians and the manufacturer, retain device serial numbers and recall letters
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Product Details
Model: S702. Devices: ACCOLADE family (ACCOLADE, PROPONENT, ESSENTIO), ALTRUA 2 DR SL and DR EL, VISIONIST CRT-P, VALITUDE CRT-P. Quantity: 4,055 units. Distribution: Worldwide. Sold by: Manufacturer through medical channels. Recall date: 2025-08-20. Notification method: Letter.
Reported Incidents
No specific injuries or incidents are detailed in the provided data. The status is ACTIVE with a HIGH hazard level.
Key Facts
- S702 model and ACCOLADE family plus VISIONIST and VALITUDE CRT-P devices affected
- Hazard level: HIGH
- Notification by letter
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Safety Guide
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