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
- Model numbers
- ACCOLADE SR SL Model L300, GTIN 00802526558900, Serial 464190, 464192, 464197, 464228, 464229, 464230 +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
ACCOLADE pacemakers are cardiac rhythm management devices used to regulate heart rhythm. The ACCOLADE family includes multiple models and CRT-P devices such as Visionist and Valitude.
Why This Is Dangerous
A software enhancement intended to strengthen Safety Architecture could prevent Safety Mode activation when battery impedance is high. This creates a risk to patient safety in ambulatory settings.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall poses a high safety risk to patients relying on these devices. Urgent action is required to stop use and contact clinicians.
Practical Guidance
How to identify if yours is affected
- Verify device is ACCOLADE family or Visionist/Valitude CRT-P.
- Check model L300 and GTIN 00802526558900.
- Review listed serial numbers to see if yours matches any.
Where to find product info
Serial numbers are on device labeling and accompanying paperwork. GTIN is on packaging. Manufacturer recall notices provide full lists.
What timeline to expect
Not specified in the recall notice. Processing for replacements or actions will be provided by the manufacturer.
If the manufacturer is unresponsive
- Escalate to the FDA recall page and seek guidance from your clinician.
- Document all communications with the manufacturer and healthcare provider.
How to prevent similar issues
- When purchasing, verify device listings with the manufacturer.
- Ensure follow-up appointments with electrophysiologists or cardiologists.
- Watch for recall updates from FDA and the manufacturer.
Documentation advice
Keep the recall letter, device identification, serial numbers, and all communications.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Brand: Boston Scientific Device family: ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2 DR SL/EL pacemakers; Visionist CRT-P; Valitude CRT-P Model numbers: ACCOLADE SR SL (Model L300); GTIN 00802526558900 Serial numbers: 464190, 464192, 464197, 464228, 464229, 464230, 464238, 464258, 464279, 464295, 464296, 464316, 464321, 464358, 464360, 464361, 464362, 464363, 464369 Distribution: Worldwide Sold since: Unknown Price: Unknown Quantity recalled: 16,077 Country of origin: Unknown
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- recalls 16,077 units worldwide
- devices include ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2 DR SL/EL pacemakers; VISIONIST and VALITUDE
- hazard involves software to enhance Safety Architecture and high battery impedance state
- stop-use-immediately and follow manufacturer instructions
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.