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, PREGNANT, INFANTS
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 (MRI)
- Model numbers
- GTIN 00802526559228, Serial numbers: 103410, 200337, 200359, 200704, 201273, 201585, 202131 +12 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 provide heart rhythm management for patients with bradycardia or heart block. MRI compatibility improves imaging but requires safe architecture. This recall concerns high impedance battery states affecting Safety Mode.
Why This Is Dangerous
Software intended to enhance Safety Architecture may fail to initiate Safety Mode during high impedance battery conditions, potentially compromising patient safety during ambulatory use.
Industry Context
This recall is not indicated as part of a broader industry pattern in the provided data.
Real-World Impact
Significant risk to patients who rely on pacemakers; immediate action required; potential device reprogramming or replacement depending on clinical guidance.
Practical Guidance
How to identify if yours is affected
- Check for model numbers L111 with ESSENTIO DR SL MRI Pacemaker among ACCOLADE family devices
- Review serials listed in official recall notices
- Look for device implantation year and lead configuration on device labels
Where to find product info
Official recall notices on FDA site and Boston Scientific notifications; serial numbers and GTINs listed in vendor communications
What timeline to expect
Recall remedies may involve device replacement or software patch; timelines vary by patient and clinical setting
If the manufacturer is unresponsive
- Document all communications with provider
- Escalate with hospital patient safety officer
- Contact Boston Scientific customer support for escalation
How to prevent similar issues
- Ensure devices are MRI-compatible with Safety Architecture; verify software version in devices
- Maintain updated patient records of device serials
- Consult clinician before any imaging or procedure involving implanted devices
Documentation advice
Keep copies of all recall notices, physician correspondence, and replacement/refund confirmations
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Model Number L111, ESSENTIO DR SL MRI Pacemaker. Devices include ACCOLADE family models and VISIONIST VALITUDE CRT-Ps. Distribution worldwide. Quantity: 223,163 units. Serial numbers and GTINs listed in records.
Reported Incidents
No specific injuries or incidents are provided in the data. The status is ACTIVE with a HIGH hazard level.
Key Facts
- Devices include ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2 DR SL/EL pacemakers
- Also includes VISIONIST and VALITUDE CRT-Ps
- High battery impedance state linked Software safety flaw
- Active recall as of 2025-10-22
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.