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
- PREGNANT, INFANTS, CHILDREN
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
- ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2 DR SL, ALTRUA 2 DR EL, VISIONIST, VALITUDE
- 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-Ps are implanted devices that regulate heart rhythm. They are critical for patients with certain heart conditions.
Why This Is Dangerous
Software intended to enhance Safety Architecture may hinder proper initiation of Safety Mode in certain battery impedance states, potentially compromising device safety.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
This recall directly affects patients reliant on life-sustaining devices and requires prompt medical guidance and remediation.
Practical Guidance
How to identify if yours is affected
- 1) Locate device model in patient records and compare to listed models.
- 2) Verify serial numbers against the recall list.
- 3) Check recall notification documentation from Boston Scientific and healthcare provider.
Where to find product info
Serial numbers and GTINs can be found on device labels and in patient records; reference recall notice for exact numbers.
What timeline to expect
Remedy process coordinated via healthcare providers; timing varies by patient and program.
If the manufacturer is unresponsive
- Escalate with the hospital's device representative
- Contact Boston Scientific customer support
- File complaints with appropriate medical device regulators if needed
How to prevent similar issues
- Verify device software updates during follow-up visits
- Maintain updated contact with device clinic
- Stay informed through official recall communications
Documentation advice
Keep all recall notices, serial numbers, GTINs, and correspondence with providers and manufacturer.
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Product Details
Brand: Boston Scientific. Products: ACCOLADE family pacemakers (ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2 DR SL and DR EL), VISIONIST CRT-P, VALITUDE CRT-P. Quantity: 7,488 units. Distribution: Worldwide. Recall date: 2025-08-20. Status: Active. Notification method: Letter.
Reported Incidents
No specific injuries or incidents are described in the provided data.
Key Facts
- Class I recall
- Software impairs Safety Mode initiation in high impedance battery states
- Affected devices include ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2 DR SL/EL, VISIONIST CRT-P, VALITUDE
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Safety Guide
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