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
- GENERAL, ELDERLY, 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
- Implantable Pacemaker
- Model numbers
- L211 PROPONENT DR SL MRI Pacemaker
- 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
Implantable devices that regulate heart rhythm used to treat bradycardia or heart blocks. These devices are implanted by clinicians in adults and certain patients may require MRI compatibility.
Why This Is Dangerous
A software update intended to improve Safety Architecture could prevent entering Safety Mode in patients with high battery impedance, potentially compromising device safety.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Patients with affected devices may require medical review and potential device reassessment. The recall emphasizes urgent consultation with clinicians and manufacturer guidance.
Practical Guidance
How to identify if yours is affected
- 1. Confirm model L211 PROPONENT DR SL MRI Pacemaker is listed in recall materials.
- 3. Review recall letter and contact your clinician or Boston Scientific for instructions.
Where to find product info
Recall letter, FDA enforcement page for Z-0089-2026, and manufacturer site www.bostonscientific.com.
What timeline to expect
Timelines depend on clinical assessment and device availability; follow recall instructions and clinician guidance.
If the manufacturer is unresponsive
- Document all communications with the clinician and manufacturer.
- Escalate to a patient advocate or appropriate medical authority if there is no timely response.
How to prevent similar issues
- Stay informed on recall updates from FDA and Boston Scientific.
- Discuss MRI needs and device compatibility with your clinician before future imaging.
- Keep all device labels and recall documentation for reference.
Documentation advice
Keep the recall letter, device model and GTINs, clinical correspondence, and any imaging or medical notes related to device status.
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Product Details
Model: L211 PROPONENT DR SL MRI Pacemaker. GTINs: 00802526559105, 00802526576409, 00802526578038. Sold worldwide through healthcare providers. Recall date: 2025-08-20. Status: ACTIVE. Quantity: 106,536 units. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Brand: Boston Scientific
- Model: L211 PROPONENT DR SL MRI Pacemaker
- Hazard: software may prevent Safety Mode activation due to high battery impedance state
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Safety Guide
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