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
- ELDERLY, GENERAL, PREGNANT
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
- Cardiac Pacemaker
- Model numbers
- L209 PROPONENT DR (VDD) SL Pacemaker, 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 are implanted devices that regulate heart rhythm. The affected line includes ACCOLADE family and related CRT-P devices.
Why This Is Dangerous
Software intended to reinforce Safety Mode may fail to initiate when a high battery impedance state is encountered, potentially impacting patient safety.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
Immediate action is required by patients and clinicians to prevent potential unsafe device operation and ensure proper management.
Practical Guidance
How to identify if yours is affected
- Verify device model against recalled list
- Check serial numbers against listed numbers (e.g., 100002, 100006 to 100026)
- Review FDA recall notice Z-0087-2026 for details
Where to find product info
Refer to the recall letter and FDA enforcement report for serial numbers and affected models
What timeline to expect
Recall processing and potential replacement or software update timelines will vary by device and clinical setting
If the manufacturer is unresponsive
- Escalate to patient advocate, hospital risk management
- File a medical device complaint with FDA if manufacturer is unresponsive
How to prevent similar issues
- Ensure devices are enrolled in a patient monitoring program
- Maintain updated clinician contact information
- Request official updates from Boston Scientific for any software patches or hardware replacement options
Documentation advice
Keep recall notification, device serial numbers, hospital correspondence, and insurer communications
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Product Details
Model Number L209 PROPONENT DR (VDD) SL Pacemaker. Devices in ACCOLADE family including ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2 dual chamber SL and EL, and VISIONIST and VALITUDE CRT-Ps. Quantity: 3,146 units. Distribution: Worldwide.
Reported Incidents
No specific injuries or incidents are described in the provided documentation.
Key Facts
- Devices affected: ACCOLADE family, PROPONENT DR (VDD) SL, ESSENTIO, ALTRUA 2 DR SL/EL, VISIONIST, VA
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Safety Guide
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