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, ELDERLY
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
- Model Number L101, GTIN 00802526559174, Serial Numbers: 100547, 100752, 100822, 100843, 100852, 100853 +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
Implantable pacemakers regulate heart rhythm for patients with bradycardia or heart failure. The ACCOLADE family covers several models used in adults worldwide.
Why This Is Dangerous
A software feature designed to enhance Safety Architecture may not initiate Safety Mode when required due to a high battery impedance state. This could affect how the device responds in dangerous scenarios.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
The recall affects patients with implanted devices. Stopping use is not user-manageable; clinical action is required. The recall could require device replacement or monitoring, with procedural risks and scheduling delays.
Practical Guidance
How to identify if yours is affected
- Review your device labeling and patient ID card for model numbers and serial numbers matching the recall list.
- Check whether the device is part of ACCOLADE family including ESSENTIO, ACCOLADE, PROPONENT, ALTRUA 2 DR SL/EL, VISIONIST, VALITUDE CRT-P.
Where to find product info
Serial numbers and model identifiers appear on the patient ID card, device box labeling, and hospital records. The recall letter from the manufacturer contains specific identifiers.
What timeline to expect
Device replacement or monitoring can take weeks to months and is arranged through your clinician. The recall notice provides steps and follow-up needs
If the manufacturer is unresponsive
- Contact your clinician for guidance.
- If you cannot reach the manufacturer or clinician, file a report with the FDA or relevant regulatory body per the recall notice.
How to prevent similar issues
- Keep patient device information up to date in your medical record.
- Regularly review medical device recalls and consult clinicians about any changes.
- Talk to your clinician before any device-related procedure or software update.
Documentation advice
Keep the recall letter, device ID numbers, hospital records, and all communications with the clinician or manufacturer.
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Product Details
Model Number L101; GTIN 00802526559174; Serial Numbers: 100547, 100752, 100822, 100843, 100852, 100853, 100857, 100863, 100865, 100866, 100868, 100871, 100874, 100879, 100883, 100884, 100889, 100891, 100892; Quantity: 22,714 units; Distribution: Worldwide; Recall Date: 2025-08-20; Remedy: Stop using the device and follow recall instructions provided by the manufacturer.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 22,714 units recalled worldwide
- Model Number L101 and ACCOLADE family identifiers
- Hazard: software to enhance Safety Architecture may prevent initiation of Safety Mode due to high-bw
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Safety Guide
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