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
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 and CRT-P devices
- Model numbers
- GTIN 00802526559471, Serial numbers: 726570, 726570, 728246, 728341, 728391, 728414, 728416 +13 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 regulate heart rhythm and are implanted in patients to manage arrhythmias. CRT-P devices like Visionist and Valitude are used to synchronize heart chambers in certain conditions. This recall covers multiple BAC devices under the ACCOLADE family and these CRT-P models.
Why This Is Dangerous
A software upgrade intended to improve Safety Architecture could inadvertently prevent Safety Mode from activating if a high battery impedance state occurs, potentially compromising device safety.
Industry Context
This recall is not described as part of a broader industry pattern in the notice.
Real-World Impact
Patients with affected devices could face safety risks if the device fails to enter required safety modes. Immediate action is advised through medical professionals to determine next steps.
Practical Guidance
How to identify if yours is affected
- Compare your device model to ACCOLADE family, VISIONIST CRT-P, and VALITUDE CRT-P models.
- Find model and serial numbers on the device label or patient records and compare with the recall list.
- Note GTIN 00802526559471 as an identifier.
- Do not attempt to modify or bypass the device without medical guidance.
Where to find product info
Recall letters, FDA enforcement report, and manufacturer communications include identifiers, steps, and contact information.
What timeline to expect
Not specified in the recall notice. Healthcare providers will coordinate replacements or other actions.
If the manufacturer is unresponsive
- Escalate to the healthcare provider or hospital's risk management team.
- Consult the FDA recall contact for guidance on unresponsive manufacturers.
How to prevent similar issues
- Maintain routine follow-up with your cardiology team.
- Ensure the device software is up to date as advised by clinicians.
- Be aware of recall notices for any implanted devices and respond promptly.
Documentation advice
Document recall notice, device model/serial numbers, clinician communications, and any replacement actions.
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Product Details
Model numbers: U228, VISIONIST CRT-P EL MRI. Devices affected include ACCOLADE family devices (ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2 dual chamber DR SL and DR EL) and VISIONIST and VALITUDE CRT-Ps. GTIN: 00802526559471. Serial numbers: 726570, 728246, 728341, 728391, 728414, 728416, 728463, 728492, 728880, 732912, 733290, 733427, 733464, 733475, 733541, 733672, 733700, 733703, 733748. Distribution: Worldwide. Quantity: 41,191 units. Sold at: Unknown. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Serial numbers list provided
- Class I recall
- High hazard level
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